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Exploration of the reasons for the overrepresentation of Black patients in schizophrenia clinical trials

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Exploration of the reasons for the overrepresentation of Black patients in schizophrenia clinical trials

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Content 1
Exploration of the Reasons for the Overrepresentation of Black Patients in Schizophrenia
Clinical Trials
by
Taisa Roma Skubiak
A Dissertation Presented to the
FACULTY OF THE USC ROSSIER SCHOOL OF EDUCATION
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF EDUCATION
August 2023
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© Copyright by Taisa Roma Skubiak 2023
All Rights Reserved

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Committee Members
Dr. Courtney Malloy, Chair
Dr. Briana Hinga
Dr. Alison Muraszewski

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Abstract
Schizophrenia clinical trials frequently are overrepresented with Black patients, and the
connection of this issue with systemic racism was not understood. This phenomenon appears to
be unique for schizophrenia, as in other indications individuals from minority communities are
often underrepresented in clinical trials. This study sought to explore the perceptions of clinical
trial staff, who were responsible for identifying and recruiting clinical trial participants, about the
reasons leading to this disproportionate representation of Black individuals in schizophrenia
clinical trials. Additionally, recruitment practices and challenges of achieving racially balanced
trials were examined. A qualitative study was conducted and 12 clinical trial site staff members
who had experience working in schizophrenia trials were interviewed. As part of an artifact
analysis, patient recruitment materials, both online and printed items, were reviewed. The themes
identified in the data analysis were assessed through the conceptual framework of
Bronfenbrenner’s ecological systems model, influenced by critical race theory. The findings
revealed that due to unequal access to healthcare and quality psychiatric care, Black individuals
with schizophrenia either seek out or are more available for clinical trials. Additionally, the
location of clinical trials sites plays a role in recruitment, as patients are identified through
convenience sampling. These inequalities are due to racial disparities that permeate all aspects of
society. Lastly, sites do not appear to be targeting Black patients with schizophrenia for clinical
trials, as similar recruitment practices are used in these studies as in other indications.
Recommendations for practice are described based on these findings. This study provided
insights into why schizophrenia clinical trials are not racially representative and added to the
importance of reducing health disparities among marginalized communities.
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Dedication
I dedicate this work to anyone who has ever doubted themselves or their self-worth.
Also, to my son.
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Acknowledgements
I would like to express my gratitude to my dissertation committee, especially my chair,
Dr. Courtney Malloy, who jumped in during the middle of my study and provided very helpful,
productive, and clear guidance. I also appreciate the time and effort of my committee members,
Dr. Briana Hinga and Dr. Alison Muraszewski, not only for their support but also for their very
thoughtful and insightful feedback.
This dissertation is solely my work; however, it could not have been completed without
the support from my fellow OCL Cohort 18 classmates. Their willingness to share their
experiences and challenges made this process much easier. I have learned so much from them
during my doctoral experience, and I am grateful for everything. Fight on!
I want to recognize my late grandfather, Dr. Alex Cybriwksy, and my late uncle, who
passed away during the data collection phase of this study, Dr. Roman Cybriwsky, as they were
my inspirations for achieving my life-long dream of earning a doctorate. They assisted me in
spirit during the most difficult periods to complete this challenging work.
To the people of Ukraine who are fighting to ward off their own oppression and
marginalization, I send my love and support. The war started during my doctoral program and
has been a critical part of my life while completing my coursework and this study about another
group of marginalized people.
To my mother, Handzia, thank you for your assistance at home to help manage my crazy
work, school, and travel schedule; I could not have done it without you. Your support has been
critical in allowing me to succeed in all aspects of my life. To my late father, Ihor, thank you for
teaching me that time is fleeting.
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To my husband, Jerrod, thank you for being my rock and life partner. You never doubted
me, even when I doubted myself. Thank you for picking up the slack. You are the best thing… I
love you.
Lastly, to my son Matei, thank you for allowing me to be your mother. I hope my
experience has taught you that you can achieve anything you want. Do not give up, especially
when things are hard, and if something is not going the way you want, make it better. These are
lessons we both have learned over the last few years. I love you and nothing will ever change
that!

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Table of Contents
Committee Members 3
Abstract 4
Dedication 5
Acknowledgements 6
Table of Contents 8
List of Tables 10
List of Figures 11
Chapter One: Introduction to the Study 12
Context and Background of the Problem 12
Purpose of the Project and Research Questions 13
Importance of the Study 14
Overview of Theoretical Framework and Methodology 15
Definitions 15
Organization of the Dissertation 17
Chapter Two: Literature Review 18
Systemic Racism 18
Systemic Racism in Psychiatry 26
Systemic Racism in Medical Research 42
Conclusion and Connection to the Study 53
Conceptual Framework 54
Section Summary 57
Chapter Three: Methodology 59
Research Questions 59
Overview of Design 60
Research Setting 61
The Researcher 62
Data Sources 63
Interviews 63
Participants 64
Instrumentation 66
Data Collection Procedures 67
Data Analysis 68
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Artifact Analysis 69
Data Collection Procedures 69
Data Analysis 70
Validity and Reliability 70
Ethics 71
Chapter 4: Findings 74
Participants 74
Artifacts 76
Research Question 1: What are the Perceptions of Clinical Trial Staff About the Factors Leading to
the Disproportionate Representation of Black Patients in Schizophrenia Clinical Trials? 77
Research Question 2: What are the Practices of Clinical Trial Staff in Recruiting Patients Into
Schizophrenia Clinical Trials? 89
Research Question 3: What are the Challenges and Barriers in Recruiting a Racially
Representative Sample in Schizophrenia Clinical Trials? 103
Summary of Findings 107
Chapter Five: Recommendations 109
Discussion of Findings 109
Recommendations for Practice 113
Recommendation 1: Do not Limit Black Patients’ Access to Schizophrenia Clinical Trials 114
Recommendation 2: Increase the Number and Funding of CMHCs 115
Recommendation 3: Expand Locations and Increase Community Engagement to Recruit
More Non-Black Individuals to Schizophrenia Clinical Trials 116
Limitations and Delimitations 118
Recommendations for Future Research 119
Conclusion 120
References 122
Appendix A 150

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List of Tables
Table 1: Data Sources 61
Table 2: Participants Overview 76
Table 3: Artifacts Overview 77

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List of Figures
Figure 1: Conceptual Framework of the Overrepresentation of Black Patients in
Schizophrenia Clinical Trials Utilizing the Ecological Systems Models Influenced
by Critical Race Theory 57

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Chapter One: Introduction to the Study
Systemic racism is prevalent in all parts of society in the United States (U.S.) and affects
the health and wellbeing of those impacted by it (Feagin, 2006). Specifically in psychiatry,
systemic racism is responsible for mental health inequities including higher rates of mental
illness, misdiagnoses, and less access to quality mental healthcare services (Compton & Shim,
2015). Medical research has historically perpetuated systemic racism with centuries of abuses of
Black individuals in the name of science, such as experimental surgeries without anesthetic and
intentionally not treating fatal illnesses (Washington, 2006). Despite current research standards,
systemic racism continues to drive disparities in modern medical research, as evidenced by an
overrepresentation of Black patients in schizophrenia clinical trials. In a snapshot of the clinical
trials completed for all new medications approved by the U.S. Food and Drug Administration
(FDA) in 2019, 9% of the participants were Black, but 75% of the participants in the clinical
trials for schizophrenia were Black (U.S. Food and Drug Administration, 2020). Though an
overrepresentation may allow for a better understanding of the experiences of a marginalized
community, the exploitation of individuals who are Black and have a serious mental illness may
be driving the differences in clinical trial participation. As there is a lack of understanding of the
specific reasons leading to the disparate participation rates, this exploratory study sought to
explore the perceptions of clinical trial staff about the factors leading to this discrepancy that is
not seen in clinical trials for other indications where Black patients are underrepresented.
Context and Background of the Problem
The context for this study was the ecosystem that conducts psychiatric clinical trials,
which is a system of multiple components. Clinical trials are medical research with human
volunteers that assess whether new treatments are safe and effective (Piantadosi, 2017).
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Pharmaceutical companies often sponsor these trials as part of the development program for a
medication or medical device, though other entities such as government agencies and academic
institutions can sponsor trials as well. The study sponsor contracts with principal investigators at
clinical trial sites to conduct the trial with patient volunteers. The principal investigators work
with a research staff that manage the administrative and coordinative aspects of the trial and are
also responsible for identifying potential participants.
Participation in clinical trials is not racially balanced as documented for many years and
in nearly all indications (Chen et al., 2018). Achieving representative diversity in clinical trials
has been a focus for decades, though disparities continue (National Institutes of Health, 1994).
Ethnic and racial minority individuals are generally underrepresented in clinical trials for many
conditions including cancer and cardiovascular disease. In psychiatry however, a different
pattern is observed as Black individuals are often overrepresented (U.S. Food and Drug
Administration, 2020). More research needs to be done to understand the reasons for the unequal
racial representation in clinical trials for schizophrenia (Hampton et al., 2009) as there may be
factors related to exploitation of this marginalized community. Additionally, the legacy of the
long history of abuses of Black individuals in medical research, such as the Tuskegee Syphilis
Study, amplifies the concern and the need for additional research (Scharff et al., 2010).
Purpose of the Project and Research Questions
The purpose of this study was to explore the perceptions of clinical trial staff, who are
responsible for identifying and recruiting clinical trial participants, about the reasons leading to a
disproportionate number of Black individuals participating in schizophrenia clinical trials, along
with exploring recruitment practices and challenges. The study centered on the staff of the
clinical trials, as they are part of the societal system that has marginalized Black individuals.
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Understanding how individuals with schizophrenia are recruited into trials can help explain why
Black individuals are overrepresented. This was explored utilizing the following research
questions:
1. What are the perceptions of clinical trial staff about the factors leading to the
disproportionate representation of Black patients in schizophrenia clinical trials?
2. What are the practices of clinical trial staff in recruiting patients into schizophrenia
clinical trials?
3. What are the challenges and barriers in recruiting a racially representative sample in
schizophrenia clinical trials?
Importance of the Study
This problem of practice was important to explore to help reduce health inequities.
Systemic racism directly and negatively impacts health (Jones, 2002), and is related to inequities
in psychiatry, including higher rates of misdiagnosis, prevalence, and poor treatment outcomes
(Shim, 2021). To create lasting improvements in health inequities, systemic racism needs to be
identified as the root of these differences and studies need to be conducted from that perspective
(Feagin & Bennefield, 2014). Separately, clinical trials are expected to be representative of the
population with the condition under study, as differences in safety and efficacy of some
medications across racial and ethnic minority groups have been reported (Ramamoorthy et al.,
2015). Though much attention is being placed on achieving racially representative clinical trials
(U.S. Food and Drug Administration, 2022), identifying the underlying factors leading to the
current imbalances is important as it maybe related to the exploitation of individuals who
participate in the clinical trials. The history of medical research abuses on Black individuals
additionally highlights the risk for similar mistreatments in this or other marginalized
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communities (Corbie-Smith, 1999). As the connection between the health inequities caused by
systemic racism and racially imbalanced schizophrenia clinical trials has not been discussed in
the literature, exploring the factors contributing to disparities in these enrollment patterns may
help to improve psychiatric health inequities.
Overview of Theoretical Framework and Methodology
The ecological systems model (Bronfenbrenner, 1994), informed by critical race theory
(Solorzano & Yosso, 2001), was used to study this problem. In the ecological systems model, the
interrelationship of the environment and the individual is examined, with a focus on the social
and cultural influences. Critical race theory has been characterized by multiple scholars and the
definition by Solorzano and Yosso (2001) was used in this study. In their conceptualization,
there are five tenets of critical race theory: race and racism center experiences, traditional
thinking is challenged, dedication to social justice, importance of the learning gained through
experiences, and the crossing of disciplines. This lens was used to understand the layers of the
ecological systems model. This combination was appropriate for examining the perceptions of
clinical trial staff about the reasons leading to a disproportionate number of Black individuals
participating in schizophrenia clinical trials, as the trial staff are part of the environment within
the system that has marginalized these individuals. As persons with schizophrenia are often not
reliable reporters, their experiences with clinical trial recruitment was explored through the
clinical trial staff as surrogates. A qualitative study with 12 interviews with clinical trial staff
who have responsibility for conducting and recruiting schizophrenia clinical trials at research
sites was conducted. This data was triangulated using artifact analysis of schizophrenia clinical
trial patient recruitment materials
Definitions
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In this section the following definitions are provided for additional context.
Clinical trials
Medical research studies that are conducted on human subjects to test the safety or
efficacy of a treatment (Piantadosi, 2017).
Health inequities
Differences in health and exposure to the associated social determinants in socially
disadvantaged individuals (Braveman & Gruskin, 2003).
Indication
The different conditions, diseases, or disorders that are the target for treatment or cure by
the medication or treatment being tested.
Principal Investigator
The lead researcher at a clinical trial site, often a physician.
Schizophrenia
A serious mental illness characterized by the presence of delusions, hallucinations,
disorganized speech, grossly disorganized or abnormal motor behavior, and negative symptoms
(American Psychiatric Association, 2013).
Sites
Also referred to as clinical trial sites or research sites, these are the hospital or outpatient
locations where clinical trials are conducted with an identified principal investigator for each
clinical trial.
Systemic Racism
Racism that is ingrained in the structure of systems in society, such as healthcare,
education, politics, and law (Feagin, 2006).
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Organization of the Dissertation
This dissertation is organized into five chapters. Chapter One is an introduction to the
problem of practice and the study background, research questions, purpose, and importance.
Chapter Two is the literature review, which explores systemic racism and the impacts in
psychiatry and medical research, including current clinical trials. Additionally, the conceptual
and theoretical frameworks are discussed. Chapter Three describes the methodology of the study,
including the design, research setting, data sources, and a discussion on the validity and
reliability. Chapter Four summarizes the findings of the study by research question, including
providing a description of the participants and artifacts. Chapter Five discusses the findings in
relation to the conceptual framework and literature, and presents the recommendations based on
the findings.
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Chapter Two: Literature Review
The topic of this dissertation is the overrepresentation of Black patients in schizophrenia
clinical trials. This will be explored through the following problem of practice: systemic racism
perpetuates non-representative clinical trials in schizophrenia. For several decades, much
attention in the U.S. has been on the lack of diversity in clinical trials and the need to correct it
(National Institutes of Health, 1994). Recent summaries have not shown a correction of
representation in trials (U.S. Food and Drug Administration, 2020). The FDA recently published
draft guidance documenting plans for continued efforts to correct this trend (U.S. Food and Drug
Administration, 2022). However, there is almost no discussion in the literature of the opposite
issue that is seen in psychiatric clinical trials, where Black patients are often overrepresented,
especially in schizophrenia clinical trials (U.S. Food and Drug Administration, 2020).
This literature review will discuss systemic racism and its impact on health, psychiatry,
medical research, and specifically, psychiatric clinical trials, to lay the foundation for the
proposed study. The chapter will begin with an introduction of systemic racism and its impacts,
followed by an exploration of its impact on health. A more detailed look into the role of
psychiatry in perpetuating racism will follow, including the unique aspects specific to
schizophrenia. Lastly, the impact of systemic racism in medical research will be discussed,
including noting historical abuses along with describing the current practice of clinical trials. The
chapter will conclude with the theoretical and conceptual framework of this study.
Systemic Racism
Systemic racism impacts all aspects of society in the U.S., as each of the systems that
comprise the culture have a role in perpetuating racism. Researchers have suggested that the
predominant societal norms at the founding of the U.S. were based on principles of racial
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inequity (Feagin & Ducey, 2019). These inequities have wide ranging impacts, including on the
health and well-being of those who are affected by them. This section will begin with a
definition of systemic racism, followed by a description of its impacts, before exploring more
deeply the resulting health inequities and access to quality healthcare.
Definition of Systemic Racism
To understand racism, one must first define race. Omi and Winant (2014) highlight that
race was socially constructed by organizing humans according to their physical appearance to
create a structure of power. By doing so, groups of people were “othered” and considered
different from the dominant White majority. This led to attempts to justify the inferiority
classification through biological or other evidence by the dominant White majority.
This belief in the inferiority of racial groups was used to justify unfair practices, policies,
and laws that comprise racism. The following definition highlights the systemic components of
racism: “a highly organized system of race -based group privilege that operates at every level of
society and is held together by a sophisticated ideology of color/race supremacy” (Casenave &
Maddern, 1999, p. 42). Several components of racism can be observed, whereas others are
covert, and this can be envisioned with an iceberg analogy (Gee & Ro, 2009). Gee and Ro state
that the visible part of the iceberg above the surface is the overt racism, including acts of
discrimination and hate crimes. However, the most dangerous part of the iceberg is under the
water and is primarily composed of the structures that create and support racist systems.
Systemic and structural racism are often used interchangeably, but there are differences.
Systemic racism considers the systems in society and how they are involved in perpetuating
racism, such as the healthcare, educational, political, and legal (Feagin, 2006). Structural racism
looks at the components of the system, specifically the structures such as laws and policies, that
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uphold racism (Bonilla-Silva, 1997). The U.S. is recognized to have been built on racist social
policies that are structurally rooted (Bailey et al., 2021). These policies have been the basis of all
of the systems in the U.S. and are deeply ingrained, making changes to the systems difficult
(Feagin & Ducey, 2019). For this paper, systemic racism will be the focus unless other
terminology was specifically used by authors, as it is understood to be broader and inclusive of
structural and other forms of racism (Braveman et al., 2022). The vast impacts of systemic
racism will be described next.
Impacts of Systemic Racism
The impacts of systemic racism are broad and wide-ranging, the details of which are
beyond the scope of this paper, so only an introduction to these concepts will be covered.
Modern medicine has evolved from the past theories of scientific racism and eugenics, where
race was seen as biologic and therefore a determinant of an individual’s ability, intelligence, and
physical features (Jackson & Weidman, 2005). These theories were used to justify white
supremacist social order and medical practices. Since that time it has been understood that the
combination of inherited factors and the influence of the surrounding environment leads to
differences between humans, and not specific biological or genetic differences (American
Association of Physical Anthropologists, 1996; Ta’ala, 2015). However, attempts to justify the
biological rationale for the categorization of humans continue today, leading to health inequities
and other fatal outcomes (Roberts, 2011). The differences seen in health outcomes based on race
have been associated with different levels of racism: institutional, personally mediated, and
internalized (Jones, 2000). Not only is the health of people of color impacted, but racism also
worsens the health of members of the dominant racial majority (McGhee, 2021). Additional
impacts include segregated living environments that will be discussed next.
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Additional impacts of systemic racism include policies and laws across multiple domains.
These include government policies that created de jure segregated cities and towns, rather than
segregation that occurred de facto due to individual choices (Rothstein, 2017). Segregated cities
and towns led to neighborhoods with less access to healthcare, substandard schools, fewer
employment options, fewer grocery stores, and higher rates of crime (Wilkerson, 2020).
Additionally, a series of unfair drug laws targeting people of color, effectively removing Black
individuals from their families, the economy, and the electorate, further perpetuate inequities in
communities of color (Alexander, 2020). These laws were created beginning in the 1970s as part
of the War on Drugs that imposed stringent penalties and incarceration times for drug crimes,
including possession of small amounts. These laws were disproportionately enforced in
communities of color, leading to higher rates of incarceration of Black individuals. These
policies and laws have an effect on individuals’ health outcomes.
Systemic Racism and Health
Systemic racism reinforces beliefs and values that are discriminatory in nature and
negatively impact health. This connection has been publicly noted by the American Medical
Association (2020) with its official recognition that racism creates health inequities and is a risk
to public health. More directly, health inequities have been connected to the experiences of
racism and its negative impacts (Feagin & Bennefield, 2014). It is understood that racism and
discrimination are stressors, the strain of which leads to negative health outcomes of racial
minority groups (Williams & Mohammed, 2013). Additionally, failure to identify racism as the
cause of health inequities further perpetuates these differences (Boyd et al., 2020). Many studies
continued to fail to name structural racism as the cause of these inequities, as seen in a review of
all articles published between 2002 and 2015 in 249 public health journals (Hardeman et al.,
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2018). In this review, only 25 articles named structural racism, or a synonym such as institutional
racism, in its title or abstract. The health inequities that are caused by systemic racism, and
perpetuated by the failure to identify as such, will be discussed next.
Health Inequities
The connection between systemic racism and health inequities has been documented in
numerous studies; this includes prejudice and bias, which Nelson (2002) emphasized as
contributory to health inequities. Jones (2002) described different levels by which institutional
racism influences health disparities. The most impactful level was how different opportunities
and experiences influenced health outcomes. The next most impactful were different access to
healthcare followed by the difference in the quality of healthcare received (Jones, 2002). Gee and
Ford (2011) note that much of the previous focus in health disparities research was on the
impacts caused by individual racism. The authors state that more recently, broader systemic
factors of social segregation, immigration policy, and intergenerational transfer of the effects of
racism have been connected with health inequities. Williams et al. (2019) provide evidence
linking the impacts of these different levels of racism with poor health outcomes, and structural
racism was noted to have the greatest effect on health. Policies such as residential segregation
alone have had negative influences on health through maintaining lower socioeconomic status,
less access to employment, weaker schools, and higher levels of crime (Williams et al., 2019).
The interaction between race and socioeconomic status has been shown to negatively influence
health, with the overall social environment and migration history additionally impacting health
outcomes (Williams et al., 2010). All of these experiences drive health inequities.
Systemic racism additionally has long-term negative health impacts on children and their
future health. A longitudinal study in Georgia and Iowa followed Black children for 18 years
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starting in 5th grade (Simons et al., 2018). Simons et al. found that exposure to segregation and
discrimination in childhood was related to increased inflammation, a marker of cardiovascular,
metabolic, immunological, and oncological diseases, as an adult. Further, the authors found the
effects of typical risk factors such as diet, exercise, smoking, and low socioeconomic status on
inflammation were much smaller than the effects of segregation and discrimination. Theall et al.
(2012) examined the relationship between neighborhood risk and the negative impacts of stress
in children that ultimately leads to poorer health outcomes as adults. Neighborhood risk was
defined as an aggregated measure of numerous factors such as rates of crime, poverty, education,
vacancy, alcohol availability, and food access. The authors found that negative neighborhood
risk had a greater role in potential future health disparities than risks within households, meaning
the impacts of the community environment outweighed those within a household.
Systemic racism also impacts multiple aspects of both physical and mental health. A
meta-analysis of 333 articles on the relationship between racism and health outcomes found that
racism was associated with poorer general health, mental health, and physical health (Paradies et
al., 2015). This impact on health outcomes was not mediated by age, sex, education, or place of
birth. An analysis of the published quantitative studies on the impacts of systemic racism on
health outcomes noted a wide range of health impacts including pregnancy complications,
cardiovascular events, cancer survival rates, stress and anxiety, and overall poor health status
(Groos et al., 2018). Additionally, Ghosal et al. found that systemic racism leads to discrepancies
in chronic pain management, with people of color often being denied necessary pain
medications. Though the health effects of systemic racism are known to be broad, more work
needs to occur to understand the scale of these effects.
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Measuring the impact of systemic racism on health inequities has lagged. In 1984, the
Task Force on Black and Minority Health was established by the Secretary of Health and Human
Services to investigate health disparities among minority populations. The task force’s report
was the first thorough assessment of the health disparities observed in non-White communities
and led a call to action to eliminate these differences (Heckler, 1985). Decades later, a review of
58 articles that specifically looked at racist experiences in healthcare settings or discrimination
by healthcare professionals showed gaps in understanding the impact of these experiences on the
receipt of healthcare (Shavers et al., 2012). This was caused by a lack of tools or methods to
examine how systemic racism impacts health disparities. Similarly, a review of the 121 articles
on the relationship of racial discrimination on the health of children found a lack of adequate
measures to fully capture the impact (Priest et al., 2013). As the challenges of measuring the
impact of inequities continue, another driver of them is access to quality healthcare.
Access to Quality Healthcare
Systemic issues that created segregated cities and neighborhoods have limited the access
to healthcare. These segregations have impacted the distribution of healthcare resources, which
lead to fewer and poorer resourced healthcare facilities in predominantly minority communities
(Bailey et al., 2017). This includes healthcare providers who have less education and experience
than those who work in other communities. Though just one of multiple factors, Williams and
Collins (2001) describe how segregation is one of the largest factors in the persistence of racial
health inequalities. Multiple examples of inequities were noted, including poorer quality of
healthcare services, higher rates of closings of healthcare facilities, and pharmacies in
communities of color stocking fewer medications thereby limiting access to appropriate
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treatments (Williams & Collins, 2001). The issues of access to healthcare lowers the quality of
care received.
Significant inequities in healthcare quality are present for Black individuals. Multiple and
different barriers to quality healthcare exist leading to health inequities for racial and ethnic
minority groups (Cooper et al., 2002). The barriers can be classified as personal, such as cultural
influence and education levels, structural, such as availability of appointments and access to
transportation, or financial, such as insurance coverage and reimbursement rates (Cooper et al.,
2002). These barriers lead to Black patients experiencing worse care on 43% of quality measures
when compared with White patients, even though there are improvements in overall healthcare
quality in the U.S. for all patients (Agency for Healthcare Research and Quality, 2021). One
quality measure noted in this report was that Black individuals are 8 times as likely as White
individuals to be newly diagnosed with human immunodeficiency virus (HIV). Black individuals
also have a death rate from HIV that is nearly 7 times higher. Other quality measures include
higher rates of developing end stage renal disease as a result of diabetes and higher rates of
hospitalization due to hypertension (Agency for Healthcare Research and Quality, 2021). Poorer
quality of healthcare drives these differences seen between Black and White populations.
Inequities in the quality of healthcare may be due to implicit biases by the healthcare
providers and the overall healthcare system. The medical diagnostic process relies on stereotypes
about group behavior and risk factors, and these are likely influenced by implicit bias (Chapman
et al., 2013). Implicit biases about racial groups negatively impact the quality of care
administered by healthcare providers (FitzGerald & Hurst, 2017). In one study of White medical
students and residents, these biases were based on false beliefs that have persisted for
generations (Hoffman et al., 2016). The authors found that half of the medically trained
26
individuals believed that Black individuals are not as sensitive to pain. Hoffman et al.
summarized that these opinions stem from the false beliefs of biological differences between
members of racial groups, and likely lead to flawed medical judgements that perpetuate health
inequities. Systemic racism has major impacts on the health inequities of individuals of ethnic
and racial minority groups, especially Black individuals, and the specific effects in psychiatry
will be discussed next.
Systemic Racism in Psychiatry
As a specialty within healthcare, psychiatry has perpetuated racism in society for as long
as the specialty has existed (American Psychiatric Association, 2021). Not only has the field
contributed to the creation of biases and misdiagnoses, but it is also contributing to the
continuation of psychiatric inequities (McKenzie & Bhui, 2007). A reckoning of this history has
led to calls for change, as more work needs to be done to address the role of racial identity and
racism in the practice of psychiatry (Talley et al., 2022). This section will review the role of
psychiatry in perpetuating racism, including understanding the complexity of Black patients with
a serious mental illness. A description of the social determinants of mental health follows, before
a deeper dive into schizophrenia epidemiology, diagnosis and misdiagnosis, and differences in
treatments and response to psychiatric care. The section ends with a discussion of the role of
systemic racism in accessing quality mental healthcare.
Role of Psychiatry in Perpetuating Racism
Psychiatry has a long history of enabling systemic racism through differences in patterns
of diagnosis and treatment, along with the conduct of research. In the antebellum South,
physician Samuel A. Cartwright theorized about what he considered were psychiatric diseases of
slaves, including drapetomania, the illness he envisioned as the cause of individuals wanting to
27
flee captivity (Willoughby, 2018). Subsequently, a stereotype developed that persisted for
generations and continues today characterizing Black patients with psychiatric illnesses as being
dangerous and unstable (Lipsedge, 1994). This stereotype impacts the quality of care received,
including a greater use of restraints and administering higher doses of potent medications.
Keating and Robertson (2004) postulate that a cycle of fear, driven by racism and prejudice,
negatively influences the relationship between Black psychiatric patients and the mental
healthcare community and perpetuates poorer mental health outcomes. The fear is on both sides
and includes the patients’ fear of mental health services as well a s the healthcare providers’ fear
of the Black community. Racism additionally complicates psychiatric outcomes for individuals
as impacts are intergenerationally transmitted, affecting both diagnosis rates and treatment
responses for subsequent generations (Lugo-Candelas et al., 2021).
According to multiple authors, there is a need to acknowledge psychiatry’s connection to
racism. Accountability for the role of psychiatry in the perpetuation of racism was raised in the
literature over 50 years ago (Sabshin et al., 1970), though many of these criticisms persist today
leading to calls for change (Talley et al., 2022). It is recognized that to correct these impacts, the
field of psychiatry must recognize and call out racism for its impact in poor mental health
outcomes (McKenzie & Bhui, 2007). In a review of 158 psychiatric records, Cermele et al.
(2001) found that patients of color were more likely to have their race or ethnicity noted in the
record. The authors describe this as a solidifying race as a defining construct of the patient and
therefore being relevant in their disease diagnosis and treatment, rather than understanding race
and ethnicity as a social construct. Additionally, this distinction centers the White patient as the
norm (Cermele et al., 2001). Psychiatric research itself can continue to drive racism, as findings
28
not often fully understood or their implications are clear, leading to misinterpretations and
erroneous application of the results (Bhugra & Bhui, 1999b).
Multiple papers link systemic racism with higher rates of mental illness. Systemic racism
and the related social injustice are noted to be at the root of inequities in psychiatry, rather than
any biological or cultural reasons that historically were blamed for these differences (Shim,
2021). Shim draws the connection between social injustice, or the unequal distribution of social
advantages, with social determinants of health that increase the risk for mental health problems.
The author argues for the need for policies to address social injustice to eliminate mental health
inequities. Other authors have made similar arguments, such as in one study that showed that
societal factors of racism, including housing, food insecurity, and income inequality led to poor
mental health outcomes (Mensah et al., 2021). Another study showed that this unequal
environment increases the risk for developing psychiatric conditions while limiting access to
mental healthcare (Kalin, 2021). Further discussions about the apologies for the systemic
relationship in psychiatry with racism and the additional challenges due to the intersectionality of
being both Black and mentally ill are discussed below.
Apologies for Racism and its Impacts
Professional organizations within both psychiatry and psychology have issued apologies
about their roles in perpetuating racism (American Psychiatric Association, 2021; American
Psychological Association, 2021b). These apologies have led to resolutions to correct past
approaches to improve mental health inequity (American Psychological Association, 2021a).
Additionally, academic journals have recognized their contributions to perpetuating racism
(Kalin et al., 2020; Ogedege, 2020), including the underrepresentation of people of color on
journal editorial boards (Shim et al., 2021). Additional criticism stems from incorrectly using
29
race as a defining characteristic of research participants or as a theoretical construct (Helms et
al., 2005). The intersection of race and mental illnesses adds an additional level of complication
upon which to reflect.
Intersectionality of Black and Mentally Ill
The intersectionality of being Black and mentally ill is an important consideration when
evaluating the impacts of systemic racism on psychiatric care. As described by Crenshaw (1989),
intersectionality is the sum of the different components making up an individual’s identity. It is
important to consider how these components together shape an individual’s experience, as it is
different from observing them independently. The intersectionality of being a member of a
racially minoritized group and having a mental health condition, among other marginalized
identities like low social status, increases disparities in mental health and quality of life (Seng et
al., 2012). Similarly, people with mental illness face discrimination due to the stigma of these
conditions (Farrelly et al., 2014). This is acutely felt with schizophrenia due to the significant
cognitive and social dysfunction that is present in this indication, which is additionally seen as a
disability (McDermott & Varenne, 1995). The intersection of being a Black individual with
schizophrenia intensifies the biases compared to one identity alone, making social inequities that
drive mental health conditions even more impactful.
Social Determinants of Mental Health
The environment in which people live is known to impact multiple aspects of health and
well-being, including mental health. The social and environmental conditions created as a result
of segregated cities and towns have been linked with poorer mental health outcomes (Compton
& Shim, 2015). These social determinants of health are systemic as they arose because of
systemic racism in our society (Harnett & Ressler, 2021). The larger the inequality in the social
30
conditions, the greater the risk for developing mental health disorders (Allen et al., 2014). In a
review of 150 studies not limited to the U.S., most found at least one socioeconomic or
demographic factor that was associated with poor mental health outcomes (Silva et al., 2016).
This led the authors to conclude that social disadvantage was a major factor in the development
of mental disorders.
Relatedly, poorer mental health has been linked to childhood trauma and stress, both of
which are experienced in environments created by systemic racism. Though not specifically
connected with systemic racism, a link between childhood trauma and future psychiatric
disorders, including schizophrenia, was documented in a study conducted in Poland (Gaweda et
al., 2021). In an analysis in the U.S., Anglin et al. (2021) connected the impacts of trauma, stress,
an individual’s neighborhood, and pre - and perinatal impacts as risk factors for developing
psychosis. This reinforced that race alone is not the risk factor, but the racism that created the
environment around the individual is the social determinant of mental health. In another study
comparing current psychiatric diagnoses and detailed histories found that childhood trauma
played a major role in the development of future psychiatric illness (Bell et al., 2015b). The
authors additionally found that childhood trauma increased the risk for misdiagnosis of these
conditions. These social determinants have major impacts on developing and diagnosing many
psychiatric conditions, including some of the most serious disorders.
Serious Mental Illness: Schizophrenia
Schizophrenia is arguably one of the most serious and debilitating mental disorders. The
Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric
Association, 2013) is the classification system of diagnosing psychiatric conditions. It lists
schizophrenia in the schizophrenia spectrum and other psychotic disorders classification, which
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includes disorders that are characterized by the presence of delusions, hallucinations,
disorganized thinking/speech, grossly disorganized or abnormal motor behavior, and negative
symptoms. To make a diagnosis of one of these disorders, all other reasons that could cause
psychosis must first be ruled out. A diagnosis of schizophrenia requires the presence of at least
two of the above-mentioned symptoms, one of which must be either delusions, hallucinations, or
disorganized speech. Additionally, the signs of the illness must be present for at least six months
with at least one of those months with active symptomatology.
According to the DSM-5, schizophrenia is a heterogeneous disorder, where individuals
can present differently with the condition, and is seen as “a constellation of signs and symptoms
associated with impaired occupational or social functioning” (American Psychiatric Association,
2013, p. 100). The DSM-5 further describes that individuals can also present with other features,
such as inappropriate affect or cognitive deficits. Though there are noticeable differences in
neuroimaging, there are no imaging or laboratory tests for the diagnosis (American Psychiatric
Association, 2013). A thorough clinical interview that considers the social, psychological, and
medical history and current symptomatology is necessary, and the diagnosis requires clinical
judgment of the trained clinician. The minority of those diagnosed with schizophrenia recover,
and most are chronically ill, either with recurring symptoms or progressive worsening of the
disorder over their lifetime (American Psychiatric Association, 2013). Additionally, mental
illness has a stigma, and the serious nature of schizophrenia compared with other mental
illnesses intensifies the stigma the patients with this illness experience (Rüsch et al., 2005).
Diagnosing this disorder has historically varied across races.
Epidemiology and Diagnosis by Race
32
Understanding the etiology and epidemiology of schizophrenia has been challenging, and
few articles in the literature have been able to clearly define these details. The etiology of
schizophrenia is not clear, though both genetic and environmental influences have a role in the
development of the disease, though in unknown ways (Tandon et al., 2008). Families with both
multiple members living with schizophrenia and others without the disorder, have been
extensively studied and the research has not been conclusive (Kolker, 2020). Schizophrenia was
previously considered to be present at consistent rates throughout the world (Häfner & an der
Heiden, 1997). However, there is evidence that the incidence of schizophrenia varies widely,
with 80% of the rates globally falling between 7.7 and 43.0 per 100,000 people (McGrath, 2005).
Additionally, there is a paradox in the diagnosis rates across races, especially in countries
with people of color in the minority. Epidemiological data does not show differences in
prevalence, though Black patients in the U.S. are clinically diagnosed with schizophrenia at
higher rates (Chien & Bell, 2008). Cohen & Marino (2013) analyzed the survey results of over
16,000 individuals and found that race and ethnicity were connected to higher rates of lifetime
experiences of psychotic symptoms, delusions, or hallucinations, with Black and Latino patients
having the highest rates. Metzl and Roberts (2014) highlight that the overdiagnosis of
schizophrenia is not due to differences in biology across races, but due to social or structural
factors. There has not been a systematic assessment of the incidence of schizophrenia or other
psychosis-related conditions by race that takes into consideration socioeconomic factors and
misdiagnoses (Anglin et al., 2021). This leads to a lack of understanding of the true rates of the
disease by race.
The difference in schizophrenia diagnosis rates in the U.S. between Black and White
patients has been noted for decades. In 1973, Simon et al. published a study assessing the
33
diagnosis rates of 192 patients in the New York State psychiatric hospitals. The authors found
that Black patients were more likely to be diagnosed with schizophrenia and less likely to be
diagnosed with depression, though there were no noted differences in the appearance of the
symptoms of schizophrenia. Over 20 years later, an assessment of diagnostic rates of 330
patients across seven locations in the U.S. showed higher rates of schizophrenia and lower rates
of psychotic depression in Black patients (Strakowski et al., 1996). Psychotic depression is
primarily an affective disorder with similar symptomatology with schizophrenia, though is
considered a less severe illness. The authors speculate that Black patients are perceived to be
more ill by the clinicians, leading to the more serious diagnosis. In a separate study comparing
the diagnosis rate of 195 Black and White patients with at least one psychotic symptom found
that Black men were more likely to be diagnosed with schizophrenia or a related condition rather
than an affective disorder (Strakowski et al., 2003). This difference was found not to be related
to the presence of more severe symptoms, but rather due to an overemphasis on the psychotic
symptoms in the Black patients by the clinicians.
Multiple authors argue that social factors, rather than biology, are related to the increased
rates of diagnosis. The rate of schizophrenia is not higher in countries where people of color are
in the majority, so any biological difference between races is not likely to be a risk factor for the
disease (Messias et al., 2007). The authors suspect that the discrimination experienced because of
being a member of racial or ethnic minority plays the bigger role. In a study of a birth cohort
between 1959 and 1967 in the U.S., Black individuals were three times as likely to develop
schizophrenia when compared to White individuals (Bresnahan et al., 2007). This incidence was
still significant, though reduced to two times as likely, after correcting for socio-economic status.
In a review of literature of schizophrenia diagnosis and race over a 24-year period, Schwartz and
34
Blankenship (2014) found a pattern of overdiagnosis in Black patients in the U.S., sometimes at
rates up to three to four times higher than for White patients. This pattern has been found in
multiple other studies. In an analysis of intake records from 19,219 patients at a behavioral
health system in New Jersey, Black patients were approximately twice as likely as White or
Latinx patients to have a diagnosis related to schizophrenia (Minsky et al., 2003). Higher rates of
schizophrenia diagnoses in Black individuals have also been noted in other countries with
predominantly White populations. For example, in a meta-analysis of research conducted in
England, Halvorsrud et al. (2019) found highest rates of schizophrenia in Black African and
Black Caribbean individuals, as well as elevated risks in other racial minority groups.
The overdiagnosis of schizophrenia in Black patients is a pervasive pattern that was not
mitigated through standardization of the diagnostic interview. In a meta-analysis comparing
studies that used structured diagnostic methods to studies that did not, Black patients were 2.4
times more likely to be diagnosed with schizophrenia (Olbert et al., 2018). Additionally, there
were no differences in the diagnosis rates with the use of standardized diagnostic tools. This
difference was also seen in a multicenter study of 610 subjects where race and ethnicity were
blinded to the clinician, and age, sex, income, site, education, and presence of an affective
disorder were controlled in the analysis (Gara et al., 2012). In a comparison of the diagnostic
rates, Trierweiler et al. (2006) found differences in how schizophrenia diagnostic criteria was
used by Black and White clinicians. They found that White clinicians were more swayed in their
diagnostic decisions by communication barriers and lack of fluency of the patients.
Schizophrenia is presently perceived to be a Black disease, with racist systems creating
this perception over the last several decades. In the late 1960s, the diagnostic criteria for
schizophrenia changed from being centered on emotional and thought disturbances to include
35
symptoms such as aggression and hostility (American Psychiatric Association, 1968). What was
seen previously as a disease predominantly of the seclusive members White middle class evolved
to a disease of violent and belligerent patients that needed to be controlled (Metzl & Roberts,
2014). As a result, the number of Black individuals diagnosed with the disease significantly
increased, and schizophrenia began to be seen as a Black disease (Lane, 2010). This shift was
also reflected in the advertisements for antipsychotic medications, with themes of meek White
women in the 1950s shifting to belligerent Black individuals in the late 1960s (Metzl, 2014). In
at least one advertisement, the individual appears angry and with their hand displayed in a fist.
As the shift in diagnostic criteria occurred during the civil rights movement and protests, a
connection was drawn between angry Black individuals who were suspicious of the police or
government and a serious mental illness (Metzl, 2009). Some White psychiatrists and
psychologists argued that participation in the civil rights protests was a “repudiation of ‘White
civilization’” and caused psychosis in Black individuals (Bromberg & Simon, 1968, p. 155). The
misdiagnosis of Black individuals continues today.
Misdiagnosis in Black Patients
Black patients are more likely to be diagnosed with schizophrenia than an affective
disorder such as depression or bipolar disorders, which are conditions that are arguably less
impairing. An analysis comparing genetic studies of individuals with bipolar disorder with their
clinical diagnosis found that Black individuals are more likely to be misdiagnosed with
schizophrenia (Akinhanmi et al., 2018). Two reasons for this disparity include inadequate
standardized diagnostic tools and poor clinical rapport between the patient and the clinician
(Baker & Bell, 1999).
36
Clinician bias has been noted as one explanation for the misdiagnosis of Black patients
with schizophrenia. A study attempting to understand the role of clinician bias in the presence of
certain symptomatology found that disorganized speech as measured by a behavioral scale was
related to Black patients being 3.7 times more likely to be diagnosed with schizophrenia than
White patients (Schwartz et al., 2019). The presence of disorganized speech was not related to an
increased rate of schizophrenia diagnosis for patients of other racial groups. Another study
documents the cultural bias clinicians have about what is perceived to be normal behavior in
Black individuals (Jones & Gray, 1986). This bias was also observed in how clinician’s
perceived other traits of the patient. Eack et al. (2012) interviewed 752 patients with
schizophrenia, schizoaffective disorder, or bipolar disorder to assess the different rates of
diagnosis of Black patients and assess potential causes. The authors found that the clinician’s
perceptions of the patient’s level o f honesty was the main driver of the discrepant diagnosis rates,
with Black patients three times more likely to be diagnosed with schizophrenia. This difference
was greatly reduced once the perception of honesty was controlled for in the analysis.
Misdiagnosis of Black patients with schizophrenia has been explained by the
misdiagnosis hypothesis, which further breaks down the role of bias. This hypothesis is
composed of two parts: clinician bias and cultural bias (Whaley, 1997). Clinician bias occurs
when the diagnostic criteria are not strictly followed. Cultural bias is the misinterpretation of
appropriate levels of mistrust in Black individuals as paranoia, which can be considered a
delusion if it is seen as rigid and not culturally explained. Though it was hypothesized that
correcting these biases can lead to more accurate diagnosis, this has not been evidenced in the
literature. In a study testing this hypothesis, different diagnostic procedures were compared for
37
24 psychiatric inpatients, and the use of structured clinical interviewing resulted in similar
diagnostic outcomes as interviews by a clinician considered a cultural expert (Whaley, 2004b).
Clinicians rely on their own judgment to interpret the presence of mistrust when it
manifests during the psychiatric evaluation, and biases can confuse mistrust with pathology
leading to a misdiagnosis. The presence of cultural mistrust, which is noted as a valid reaction to
dealing with systemic racism, has been connected with misdiagnosis of schizophrenia (Whaley,
2001b). A comparison of different diagnostic methods of 118 hospitalized psychiatric patients
showed that cultural mistrust in patients was more likely to result in a subtype diagnosis of
paranoid schizophrenia if the clinician was not a culturally sensitive expert (Whaley, 2001a). In a
separate analysis of the same sample, no relationship was found between the presence of racial
themes in the psychotic symptoms, such as believing that their thoughts were controlled by “the
White man”, with receiving a diagnosis of schizophrenia or the paranoid subtype (Whaley &
Hall, 2009, p. 462). Therefore, it appears that the cultural bias and mistrust are more influential
in misdiagnoses in the patient’s general presentation rather than within the context of their
psychotic symptoms. Racism has been described as “prejudice plus power” by Tatum (2001),
and the clinician is in a position of power over the patient. The misdiagnosis by the individuals in
power perpetuates the system of racism, as a diagnosis of schizophrenia can have vast impacts on
stigma and future opportunities for the patient, including differences in the treatment and
response to medications.
Race and Psychiatric Medication
Differences have been noted with racial and ethnic minority groups on the need for
treatment and willingness to use psychiatric medications. Using data from the General Social
Survey, Schnittker (2003) assessed the perceived willingness of individuals to use psychiatric
38
medications. Black individuals were noted to be more concerned about the efficacy and safety of
these treatments, which resulted in being significantly less willing to use these medications. In an
analysis of a survey of 232,723 individuals, the perceived need for mental health treatment was
assessed across ethnic and racial groups and found that all non-White ethnic and racial groups
reported less need of mental healthcare (Breslau et al., 2017).
Similarly, lower adherence rates for psychiatric medications have been reported for
members of racial or ethnic minority groups. Even after controlling for factors such as social
support, Black patients had lower adherence across all types of psychiatric medications including
antipsychotics, antidepressants, and mood stabilizers (Diaz et al., 2005). The adherence rates
were also lower when compared to both monolingual and bilingual Latinx patients, though the
difference was not statistically significant. These differences may be explained by findings that
Black patients are more likely to be prescribed medications with more severe side effects,
leading to greater premature discontinuation rates (Herbeck et al., 2004). In this study, Herbeck
found that Blacks patients were less likely to receive second generation antipsychotics, which
may have higher adherence rates than older medications.
Several studies have shown that response and adverse events rates to psychiatric
medications have also varied across racial groups. Differences in the metabolism and therapeutic
effect of medications have been noted by race and ethnicity (Bhugra & Bhui, 1999a). Also,
differences in pharmacokinetic clearance of antipsychotic medications have been reported, with
Black patients clearing perphenazine faster than other races (Jin et al., 2010). The authors
indicated this difference is possibly explained by the presence of a polymorphism that alters the
metabolism rates, which may be more heavily present in Black individuals than in other races.
Individual genetic ancestry has been linked with dopamine receptor availability, which also may
39
play a role in the response rates and side effect profile of psychiatric medications (Wiers et al.,
2018). Another study found that non-White individuals with schizophrenia were more likely to
develop tardive dyskinesia, a disorder characterized by repeated and involuntary muscle
movements (Tenbeck et al., 2009). However, some of these connections are not well understood,
as a study that was designed to look for different outcomes for safety or efficacy of
antidepressant treatment by race showed that there were no differences for Black patients after
controlling for baseline differences in the sample (Lesser et al. 2011).
Current scientific thinking is that race is not the distinguishing factor in these differences,
especially due to the socially constructed nature of race. The differences in medication response
may be best explained by genetic variations rather than racial differences (Jones and Perlis,
2006). Historically, race has been used as a proxy for genetic variations, though that is a
misguided approach. Jones and Perlis speculate that once individual pharmacogenetic
assessments become more widely available, that will be the more accurate predictor of
medication response. As noted by Martin et al. (2019), genetic risk prediction is not yet
developed in psychiatry, though work is continuing. Following this reasoning, there is a call for
research that focuses on patients’ individual genetic disposition rather than using race as a major
distinction (Saulnier & Dupras, 2017). However, the social construction of race does have clear
impacts on access to quality care.
Accessing Quality Psychiatric Care
With higher rates of psychiatric conditions, access to quality psychiatric care for patients
in racial and ethnic minority groups is necessary for accurate diagnosis and treatment. Systemic
racism reduces the availability of healthcare, which is acutely felt in psychiatry. Both the lack of
access to and the lower quality of mental healthcare will be described below.
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Lack of Access to Mental Health Care
Access to mental healthcare is a persistent problem for patients from racial minority
groups. In a study comparing the rates of access to mental healthcare between 2004 and 2012,
disparities for patients in racial minority groups increased during this time, mostly driven by lack
of access to psychiatric medications (Cook et al., 2017). Numerous reports have shown that
patients in racial minority groups not only have less access to mental healthcare, but also are less
likely to receive care. According to the Substance Abuse and Mental Health Services
Administration (2020), 42% of Black adults with a serious mental illness in the U.S. received no
treatment in 2019. One of the main factors noted to be a barrier to accessing mental health
treatment is cost (Alang, 2019).
Emergency and inpatient psychiatric treatment is more highly utilized by Black patients,
suggesting lower access to outpatient services. Data collected in a survey of patient
characteristics of New York state funded psychiatric programs showed that Black individuals
were significantly more likely to use emergency psychiatric services (Chow et al., 2003). Black
men who were mental health patients were 3.54 times more likely to be hospitalized than similar
White men (Whaley, 2004a). In a chart review of psychiatric hospitalizations of 1,481 patients,
Black individuals were half as likely as White patients to be referred to psychiatric aftercare
services (Thompson et al., 2003). These differences may be limited to the levels of service. In an
analysis of the relationship between race and the length of time between onset of psychotic
symptoms and the receipt of treatment, Black patients received care at least as quickly as patients
of other races, and in some studies, received care faster than White patients (Anderson et al.,
2014). The challenges with accessing care is related to inadequate treatment options.
Inadequate Psychiatric Treatment
41
Multiple studies have shown that the quality of psychiatric care is critical for accurate
diagnosis and treatment, though this is not equal across racial groups. A comparison of the
current psychiatric diagnosis with their detailed childhood medical history for 330 Black patients
showed that 89 of them were misdiagnosed as childhood history was not taken in account (Bell
et al., 2015a). Black patients additionally have much lower use of minimally adequate healthcare
when compared to White patients (Ault-Brutus, 2012). Minimally adequate healthcare was
defined by the number of visits to a mental health practitioner and/or prescriptions for psychiatric
medications such as antidepressants or anxiolytics. This trend has been noted for some time, as
in an older study, a chart review of 22 patients in an outpatient psychiatric clinic noted a
connection between receiving treatment in a publicly funded and therefore less resourced facility
resulted in poorer care and misdiagnoses (Bell & Mehta, 1981).
These discrepancies in treatments for Black patients are seen in serious mental illness as
well. A database analysis of Medicaid claims and prescription data showed that Black patients
are less likely to receive second generation antipsychotic medications, which are generally
accepted to be at least as effective and safer than first generation antipsychotics (Lawson et al.,
2015). Similar results were found in an analysis of prescription rates of patients in Rochester,
New York community mental health centers (Mallinger et al., 2006). In this study, the authors
speculated that physician bias about patient symptomatology drove the difference in treatment
patterns. Kuno and Rothbard (2002) found discrepancies in the prescription rates for oral
antipsychotic medications such as risperidone and clozapine. The difference in the rates of use of
clozapine between White and ethnic and racial minority patients persists and was noted in all 16
studies analyzed by Williams et al. (2020). This difference is concerning as clozapine is known
to be the preferred treatment for patients with refractory schizophrenia.
42
In recent years, there has been a greater recognition of the role of systemic racism in
driving treatment inequities in psychiatry. The American Psychological Association (2021c)
noted that racism is connected to inadequate treatment options for patients with mental health
needs. The unconscious bias of the clinicians is associated with lower quality of mental
healthcare (Moreno & Chhatwal, 2020). Additionally, the negative impact of racism is passed
down through generations, complicating treatment and response (Price et al., 2022). These
disparities have been noted across psychiatric conditions, including depression (Moise &
Hankerson, 2021). Furthering the inequities, inadequate mental health treatment has been shown
to lead to disconnection from the mental healthcare providers, leading to even poorer outcomes
especially for patients in racial minority groups (O’Brien et al., 2009).
Similar discrepancies in treatment were seen in other countries where Black individuals
are also in the minority. In a study in the United Kingdom (U.K.), data from the National Audit
of Schizophrenia surveys of mental health trusts within the National Health System found that
there were different treatment patterns for minority patients (Das-Munshi et al., 2018). The data
for 10,512 patients across the trusts were analyzed, and it was found that minority patients were
less likely to receive the best standard treatments available when compared to White patients.
Additionally, they described situations of possible coercion in identifying schizophrenia
treatment options in minority patients that were not observed with White patients. The impact of
systemic racism continues to be seen across the healthcare industry, including research.
Systemic Racism in Medical Research
Medical research is generally conducted with humans as the research subjects. As such,
ethical standards are in place to ensure the protection of human subjects, though this was not
always the case, with disastrous consequences. Clinical trials will be the focus of the current
43
medical research in this paper, and some of the current issues are related to the distribution of the
race and ethnicity of the participants, with psychiatric trials standing out for having the opposite
issue with diversity. This section will begin with an overview of the current ethical standards in
medical research before exploring the historical abuses of humans, specifically Black
individuals, in the name of science. Next, a discussion about diversity in current clinical trials,
which is a frequently discussed topic, will occur, including describing some of the most well
understood reasons for these disparities. Finally, the focus will turn specifically to psychiatric
clinical trials that have a unique issue with diversity with the overrepresentation of Black
patients, especially in trials for schizophrenia.
Ethics in Medical Research
Due to the nature of what is being studied, much of medical research occurs in human
subjects. Currently researchers are expected to comply with numerous ethical safeguards,
including Institutional Review Board (IRB) approvals of the research. In 1964, the ethical
principles of conducting research on human subjects was encoded in the Declaration of Helsinki
(World Medical Association, 1964). This document has been revised seven times to maintain
currency and remains the standard to which researchers are expected to comply (World Medical
Association, 2013). The main principles of this declaration include the need for research subjects
to provide informed consent to voluntarily participate in studies and that the welfare of the
research subjects supersedes any perceived needs of science or the community. These ethical
principles are an important advancement following a long history of unethical experimentation.
Historical Abuses in Medical Research
Medical research has historically used Black individuals as involuntary subjects of
experimentation, the impacts of which are still being understood by the research community.
44
Washington (2006) described numerous examples of surgical, medicinal, medical device, and
genetic experiments on unknowing Black individuals over the last 400 years. Historically, female
slaves were blatant targets of surgical experimentation (Roberts, 1996). A prominent physician
from the mid-1800s, Marion Sims, developed a surgical procedure to correct a complication of
childbirth called vesicovaginal fistulas by experimenting without anesthesia on enslaved women
(Wall, 2006). One of these women endured 30 such surgeries. Other researchers attempted to use
science to “cure” physica l differences between races. In 1799, the father of modern psychiatry,
Benjamin Rush, wrote about black skin as a type of leprosy and named it negritude (Martin,
2002). Rush suggested it could be cured by violently rubbing the skin or with the use of acids
and documented the experiments that other physicians conducted to test the effectiveness of
these skin whitening techniques. Many Black individuals were paraded at various exhibits both
for medical curiosity and entertainment of White audiences. More recently, tissue taken from
Henrietta Lacks, a Black woman who died from cervical cancer in 1951, were obtained without
her consent and subsequently used to research and develop new treatments, vaccines, and
procedures without acknowledgement of their origin (Skloot, 2010).
One of the best-known examples of medical research abuse was the Tuskegee syphilis
study, where Black men with syphilis were misled and left untreated as researchers wanted to
examine the natural progression of the disease (Jones, 1993). Approximately 600 mostly poor
and illiterate Black men from Macon, Georgia were recruited into the study with no informed
consent but were offered strong enticements for participation such as transportation, free medical
care, and paid burial. Nearly 400 of the participants were found to have latent syphilis. They
were followed from 1932 to 1972 and were not informed of their condition. Even though new
treatments were developed for syphilis in the mid 1940’s, such as penicillin, they were withheld
45
from the participants. Though questions of the ethics of withholding effective treatments began
in the early 1950’s, the study continued for several decades on the rationale that the risk -benefit
assessment supported continuation. The legacy of the Tuskegee syphilis study has impacted the
perceptions of medical research and highlighted not only the abuses of Black individuals in
research but also the risk for similar mistreatment of any vulnerable and marginalized
community (Corbie-Smith, 1999). The impact of this study is felt today, with a realization that
people of color, especially the Black individuals historically exploited, are least likely to be
helped from the learnings gained from these experiments (Titanji & Swartz, 2021). Current
research, including clinical trials, attempt to overcome these deficits.
Current Medical Research and Clinical Trials
Although medical research spans a vast array of different work, from basic laboratory
research to testing in humans, the focus of this paper is on clinical trials. Clinical trials have been
defined as “an experiment testing a medical treatment on human subjects” (Piantadosi, 2017, p.
21). These experiments are carefully designed to understand whether the medical treatments are
safe and effective. External influences are controlled to limit bias, and the results are statistically
analyzed. The trials are often short term, with the duration of treatment extending from a few
hours to several months. At the end of the trials, participants are often referred to their non-
research healthcare provider to resume routine care, but there is no set process to ensure this step
occurs (Piantadosi, 2017). Volunteers who meet the eligibility criteria are enrolled, and a
protocol describing the required assessments and timepoints is strictly followed. Piantadosi
describes that current clinical trials are often sponsored by pharmaceutical companies, who
contract with research physicians globally to execute the trials, though other organizations such
as non-profits or government agencies may also sponsor clinical trials. As described above, as
46
clinical trials are research conducted on human subjects, they are required to follow ethical
principles for protections of the participants. One of the current concerns in trials is whether they
are appropriately representative of the population being studied.
Problems with Lack of Diversity in Clinical Trials
As clinical trials assess the safety and efficacy of medications, it is important that they are
conducted in the representative patient populations with the disease. Most clinical trials struggle
with a lack of diversity and an overrepresentation of White participants (U.S. Food and Drug
Administration, 2020). This issue has been discussed for several decades following the issuance
of Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research by the
National Institutes of Health (National Institutes of Health, 1994). These guidelines required
clinical trial sponsors to include women and individuals from minority racial groups in trials to
ensure the research participants are representative of the population with the illness.
Multiple clinical trials across indications report fewer participants from minority groups
than expected when compared to the general population. In a review of the racial and ethnic
breakdown of the clinical trials submitted to the U.S. FDA for all new medications approved
from 2013 to 2015, Black participants represented 6.4% of the study participants (Chen et al.,
2018), compared to the population estimate of 13.4% in the U.S. (U.S. Census Bureau, 2021).
This is a continuation of a trend that was observed earlier in a similar analysis for medications
approved by FDA between 1995 to 1999, where the representation of Black participants was 8%
(Evelyn et al., 2001). Similar trends were reported in other countries with White majority
populations. A review of clinical trials conducted in the U.K. showed that South Asians, the
largest minority groups in that country, represented 0% - 1.7% of the clinical trial population,
even though the trials were conducted in communities with high concentrations of this
47
population (Hussain-Gambles et al., 2004). The opposite pattern was reported in a review of 41
studies that employed FDA’s exception from informed conse nt pathway (Feldman et al., 2018).
This exception allows researchers to enroll study participants without obtaining informed
consent due to experiencing a life-threatening condition without available treatments and a
narrow window to initiate the experimental treatment. Feldman et al. found that 29% of the study
participants were Black though the reason for their overrepresentation was not clear, other than
speculation from the authors that the trial sites were located in areas with large Black
populations.
Representative diversity in clinical trials is important so that the study results characterize
the safety and efficacy in the patients who eventually may use these medications. The
importance of this was highlighted by Ramamoorthy et al. (2015), who found that different
safety or efficacy profiles are seen in some medications across racial and ethnic groups. Only 9%
of the participants in the clinical trials for the 48 new medications approved by the U.S. FDA in
2019 were Black (U.S. Food and Drug Administration, 2020). A similar disparity is seen across
subgroups, as participants across all ethnic and racial minority groups are underrepresented in
most clinical trials. As research helps guide the understanding of the most appropriate treatments
for patients, without appropriate levels of minority patient participation in clinical trials, cancer
death rates may increase as the optimal treatment options cannot be determined for these patients
(Chen et al., 2014). However, other studies have cautioned that even if clinical trials were
representative of the population, it would still be difficult to come to meaningful conclusions
about the safety and efficacy of medications in some racial or ethnic minority groups as the
numbers would be too small (Miranda et al., 2003). Though there has been an improvement over
time, rates of participation by patients from ethnic and racial minority groups are not adequate
48
and further improvements are needed. Several barriers to clinical trial participation have been
documented in the literature including a lack of awareness of clinical trials and a mistrust of
medical research.
Lack of Awareness of Clinical Trials. Lack of awareness of clinical trials is known to
lead to lower participation rates. Langford et al. (2010) found that Black and Latinx individuals
are less likely to be aware of clinical trials. Even after controlling for socioeconomic factors such
as income and education levels, Black and Latinx respondents to a national health survey were
significantly less aware of clinical trials than White respondents. A study by Brown and Moyer
(2010) found that awareness of clinical trials is related to having positive feelings about medical
research. The authors found that Black, Latinx, and Asian American respondents to a national
health survey were less likely to be aware of clinical trials, but those who were aware of them
were more likely to feel positive about the use of health data for research purposes. Similarly,
Wallington et al. (2011) found that knowing about clinical trials leads to increased willingness to
participate in them. In their study of Latinx survey responders, 71% of those who knew about
clinical trials stated that they would participate in a clinical trial compared to 60% of those who
did not know about clinical trials. Therefore, patients from racial or ethnic minority groups are
less likely to be aware of clinical trials, so they are less likely to be included in them. However,
awareness is only one barrier to clinical trial participation; other challenges exist related to
medical research that are especially prevalent for minority communities.
Mistrust of Medical Research. Mistrust of medical research, stemming from historical
abuses and other impacts of systemic racism, is often cited as a barrier to clinical trial
participation. George et al. (2014) reviewed 44 studies that assessed the barriers to health
research participation in minority groups, and mistrust was noted to be a barrier in 77% of these
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studies. In another study, a series of focus groups identified that mistrust was the main barrier for
the lack of participation in medical research by Black adults (Scharff et al., 2010). Knowledge of
past atrocities such as the Tuskegee syphilis study and the perception of ongoing mistreatment of
Black patients in medicine were noted as drivers of this mistrust. Concerns about being used as
“guinea pigs” are often cited by minority patients as reasons they do not want to participate in
research (Rivera-Goba et al., 2011). The authors utilized focus groups to assess how Latinx and
Black HIV patients make decisions about participating in clinical trials, and Black individuals
specifically referenced the Tuskegee syphilis study and their concerns of being tested upon as
reasons not to participate. However, a study that employed a questionnaire on the legacy of the
Tuskegee syphilis study showed that other than for Black residents of the city of Tuskegee,
awareness of the study did not impact Black individuals’ willingness to participate in medical
research in other locations in the U.S. (Katz et al., 2008). It is important to note that though many
studies point to mistrust as a barrier to clinical trial participation, Jaiswal and Halkitis (2019)
describe the dangers of this cultural framing as it places the blame on the communities of color,
rather than identifying the systemic racism at the root of this justified mistrust.
Even with questions of mistrust, several studies have noted that individuals across racial
and ethnic minority groups are willing to participate in clinical trials if they knew about them. In
a review of screening rates of over 70,000 interested participants for 20 medical research studies
found that patients from ethnic and racial minority groups were slightly more willing than White
patients to participate in the research (Wendler et al. 2006). The authors found significant
differences across ethnicity and race in the rates of being invited to participate, highlighting that
the process of research staff identifying potential subjects drives the resulting patient distribution
in trials. Similarly, a study that compared consent rates by race for a cardiovascular trial found
50
that there were no differences between Black and White patients (Corbie-Smith et al., 2003).
They also noted that age, medical history, and previous medication experience were predictors of
study participation across races. Interestingly, psychiatric clinical trials have a demographic
representation that is unique from most other trials.
Current Psychiatric Clinical Trials
Psychiatric clinical trials also have issues with diversity in clinical trials, though they are
different from what is seen in other diseases as Black patients tend to be overrepresented. Mak et
al. (2007) reviewed 379 clinical trials funded by the National Institute of Mental Health
published between 1995 and 2004 found that other than Black patients, racial and ethnic
minority groups were underrepresented. Black patients represented 25.4% of the aggregated
study sample. A review of the literature in a related field, applied psychology, also found an
overrepresentation of Black participants at 16.4% of the study (Case & Smith, 2000).
Additionally, psychiatric clinical trials have been lagging in reporting the racial and
ethnic breakdown of the study participants. In the study noted above, less than half of the trials
reviewed included a complete breakdown of participants by race or ethnicity (Mak et al., 2007).
This number appears to be increasing, as a review of 75 clinical trials in four psychiatric
conditions conducted between 2001 and 2010 found that 89% of the studies reported ethnic and
racial breakdown of the participants (Santiago & Miranda, 2014). In a review of 342 clinical
trials for depression over a 36-year period, both reporting of race and ethnicity of participants
and enrollment of participants in racial and ethnic minority groups has increased over time,
though more progress is needed (Polo et al., 2019). Similar information for schizophrenia clinical
trials is not readily available in the literature.
Schizophrenia Trial Participation
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Clinical trials in schizophrenia are often short-term studies assessing the safety and
effectiveness of an investigational medication against a placebo, an active treatment, or both
(Correll et al., 2022). As the treatment arm is often assigned randomly and is blinded to both the
participants and the researchers, at trial completion the actual treatment received is not yet
known. Though many of these details are consistent with clinical trials in other conditions
(Friedman et al., 2015), the added challenge of schizophrenia places these participants at higher
risks of not following through with their aftercare plans. Additionally, it is known that some
participants become repeat clinical trial participants and sequentially join multiple clinical trials
over a period of time.
Schizophrenia clinical trials are known to be overrepresented with Black patients, though
no articles in the literature discuss this issue. Examples of the overrepresentation are not difficult
to find. Though not intended to be a systematic review, several examples include a study of the
olanzapine with 38.3% Black participants (Stauffer et al., 2010), a comparison of aripiprazole
and paliperidone with 27% Black participants (Naber et al., 2015), two studies with lurasidone
with approximately 34% Black participants each (Meltzer et al., 2011; Nasrallah et al., 2013), a
study with cariprazine with 26.8% Black participants (Marder et al., 2019), a study with
lumateperone with 66.4% Black participants (Correll et al., 2020), and two studies with
brexpiprazole with approximately 24% Black participants each (Correll et al., 2015; Kane et al.,
2015). The direct comparison of these studies is not possible due to several factors. Many of
these trials were conducted in multiple countries with different racial demographics in addition
to the U.S., in regions such as western Europe, eastern Europe, Asia, and South America, though
the contribution of each region varies. None of the trials were conducted in Africa or countries
with a Black majority. Reporting of participants by race and country is rare, so the proportion of
52
Black patients enrolled in the U.S. is very difficult to determine. Additionally, the differences of
how race is categorized and reported globally leads to challenges with making meaningful
comparisons, other than observing that Black patients, for which the clinical trial staff have the
responsibility for recruiting, appear to be overrepresented.
Trial Recruitment Practices
The staff at clinical trial sites play a critical role in recruiting patients into trials. Study
coordinators are “at the center of the clinical research enterprise” and have a role in planning for
and executing nearly all aspects of the clinical trial (Davis et al., 2002, p. 411). They have been
identified as a key role in participant recruitment, enrollment, and retention (Clark et al., 2019).
Further, the research staff has been noted in focus groups of clinical trial participants to be highly
influential in the potential participant’s decision -making process, additionally highlighting the
criticality of these roles in recruitment of participants (Griffith et al., 2020). Customization of
recruitment activities has been suggested to assist with recruitment of potential participants from
various demographic groups, highlighting the importance of these activities in influencing
recruitment results (Kurt et al., 2018).
Recruiting potential participants is multifaceted. Recruitment into clinical trials often is
based on convenience sampling, where research investigators enroll participants to which they
have access (Catlin & Van Hecke, 2021). In a study comparing the eligibility and participation
rates across races for cancer clinical trials, subjective opinion of the clinical trial staff was noted
as a major reason why subjects were not considered eligible for a clinical trial (Penberthy et al.,
2012). Similar findings were seen in assessment of recruitment barriers for a trial of individuals
with serious mental illness, where the biases of the research staff greatly influenced who was
asked whether to participate in the trial (Howard et al., 2008). Additionally, Tanner et al. (2015)
53
noted that the perceptions of the research investigators are critical in understanding the patterns
in the patient demographics recruited at their site. Also, the influence of the individual’s non -
research mental healthcare professional is important in the decision making for the patient, so the
relationship between the clinical trial staff and the mental healthcare professional is noted as an
important factor (Jørgensen et al., 2014). Other studies have shown similar findings with the
non-research clinician being an important influencer for trials in first episode psychosis
(Furimsky et al., 2008). In a study that looked at the recruitment challenges of Asian American
individuals into schizophrenia clinical trials, it was noted that a subjective assessment of an
individual’s ability to provide consent was an initial filter on deciding who may be a good trial
candidate (Lim et al., 2020). Given the concerns of systemic racism’s influence in psychiatry and
research, this raises questions whether the same level of filter is applied for Black individuals.
Potential participants decide whether they want to join a clinical trial, and several
additional factors influence that decision. A review of 40 studies identified the rates of decision-
making capacity for treatment or research decisions of inpatients with schizophrenia and found
that approximately half had enough insight and cognitive performance even in their acutely ill
state to make these decisions (Spencer et al., 2017). Hampton et al. (2009) found that patients
with serious mental illness who were in need of healthcare may be more motivated to participate
in research as a means of access to care. The differences between what is seen in schizophrenia
clinical trials when compared with the other diseases are complex.
Conclusion and Connection to the Study
Systemic racism permeates all aspects of our society, with many negative impacts for
those affected by it. Among the largest impacts are health inequities that are the result of unequal
policies across multiple systems. Mental health inequities are also prominent, with the stress of
54
racism being connected to poorer mental health outcomes, and misdiagnoses due to biases and
lack of cultural sensitivity. Medical research also has been impacted by systemic racism, starting
with centuries of abuses of Black individuals in research and leading to unequal representation of
ethnic and racial minorities in current clinical trials. Psychiatric clinical trials, in particular
schizophrenia, have a unique situation with an overrepresentation of Black patients, likely the
result of the role of psychiatry in perpetuating racism in addition to systemic factors. Since there
is not a peer-reviewed study on the reasons for the overrepresentation of Black patients in
schizophrenia clinical trials, this study adds to the understanding of why this phenomenon occurs
in hopes of finding solutions to help reduce mental health inequities. This study used
Bronfenbrenner’s (1994) ecological systems model informed by Solorzano and Yosso’s (2001)
critical race theory to examine the problem of practice of systemic racism perpetuating non-
representative clinical trials in schizophrenia.
Conceptual Framework
The ecological systems model (Bronfenbrenner, 1994), informed by critical race theory
(Solorzano & Yosso, 2001), was used to study this problem. In the ecological systems model, the
interrelationship of the environment and the individual is examined, with a focus on the social
and cultural influences. This model can be visualized as five concentric circles, each of which
representing an ecological layer. The circle in the center represents the individual and the
subsequent layers gradually expand to larger environmental systems. The microsystem is
immediately next to the individual, and includes family, school, work, neighborhood, and other
immediate relationships. The next layer is the mesosystem, which is the interaction of the
microsystem with the subsequent layer, the exosystem. The exosystem represents the larger
community and available resources. The fifth layer is the macrosystem, which are the overall
55
societal and cultural influences. Bronfenbrenner revised the model later to also include the
chronosystem which underlays all layers and represents changes over time.
Critical race theory has been characterized by multiple scholars, though the definition by
Solorzano and Yosso (2001) was used in this study. In their conceptualization, there are five
tenets of critical race theory. The first tenet is the centrality of race and racism, meaning that
racism is pervasive and permanent in society. The second tenet is the challenge to the dominant
ideology in which typical beliefs such as race neutrality and meritocracy are questioned. The
third tenet is commitment to social justice, which is a transformational response to oppression.
The fourth tenet is the centrality of experiential knowledge, highlighting that the experiences of
individuals of color are valid and critical to understanding the impacts of racism. The last tenet is
a transdisciplinary approach incorporating aspects of other fields such as sociology, history, and
law. This lens was used to understand the layers of the ecological systems model
(Bronfenbrenner, 1994).
The ecological systems model (Bronfenbrenner, 1994) informed by critical race theory
(Solorzano & Yosso, 2001) was appropriate for examining the problem of an overrepresentation
of Black patients in schizophrenia clinical trials, as unequal representation of subjects in trials is
due to the influences in the patient’s environment where race plays a major role. Though
participation in clinical trials is voluntary, the research investigator and their staff are responsible
for finding potential participants. The investigator and staff are recruiting participants who are
most convenient for them. Due to systemic racism, which impacts the availability of mental
healthcare and social services, this is predominantly Black individuals. Once approached to
participate in the trial, the individual makes the decision on whether to proceed, though this may
be influenced by their family, psychiatrist, social worker, and other aspects of their social
56
support network. Lastly, other factors, such as housing, access to healthcare, and location play a
role. This interrelationship of the individual and their environment is an important factor of
clinical trial participation motivations, all of which is influenced by race and racism.
Through a critical race theory (Solorzano & Yosso, 2001) lens, the influences that occur
across the layers of the ecological systems model (Bronfenbrenner, 1994) was examined to
understand the overrepresentation of Black patients in schizophrenia clinical trials. The
individual at the center of the framework is a Black adult with a schizophrenia diagnosis. In the
microsystem, the influences on the individual include their psychiatrist and other mental health
professionals, the social worker and other social support providers, family members, and
religious community. All of these have their own beliefs and biases that have an impact on the
patient. The mesosystem includes the individual’s living situation, access to mental healthcare
and social services, and availability of transportation, all of which may be uniquely experienced
for Black patients when compared to others. The exosystem will include the community where
the individual lives, the structure of the mental healthcare network, the legal system, and the
social support services that are locally available. Similar to the mesosystem, the patient’s
experiences in each of these areas is impacted by their race. The macrosystem includes systemic
racism, the marginalization of the seriously mentally ill, and the distrust of the healthcare system
by Black individuals. Lastly, the chronosystem, which underlies all of the previous ecological
systems layers, includes the historical medical research abuses of Black individuals, the
deinstitutionalization of the mentally ill and the lack of social support services that followed, as
well as the patient’s individual treatment history. The representation of this framework used in
this study is depicted in Figure 1.

57
Figure 1
Conceptual Framework of the Overrepresentation of Black Patients in Schizophrenia Clinical
Trials Utilizing the Ecological Systems Models Influenced by Critical Race Theory

Section Summary
Psychiatric clinical trials, specifically in schizophrenia, exhibit a distinctive pattern of
participation of Black individuals, and this difference is explained by systemic racism. Systemic
racism is also the cause of the inverse situation seen in clinical trials for other diseases, but the
unique history of psychiatry in the perpetuation of racism has influenced these studies in a
different way. The overdiagnosis of Black patients with schizophrenia may also contribute to the
higher participation rates in the trials. Further, the history of abuses of Black subjects in medical
research and the continued risk for exploitation of marginalized groups raises ethical questions in

Schizophrenia diagnosis
Black
Adult

Psychiatrist
Social worker
Family
Religious community

Living situation
Access to services
Availability of transportation

Community
ental health care network
Legal system
Social support services

Systemic racism
arginalization of seriously
mentally ill
Distrust of health care
system by Black individuals

History of medical research abuse on
Black individuals
Deinstitutionalization of seriously
mentally ill
Individual psychiatric treatment history
58
how potential participants are recruited into schizophrenia clinical trials. These concerns about
research participation needed to be further investigated.

59
Chapter Three: Methodology
This chapter describes the methodology used for this study, the purpose of which was to
explore the perceptions of clinical trial staff on the reasons for the disproportionate number of
Black individuals participating in schizophrenia clinical trials. This was important to research as
no studies in the literature have explored this topic, though trials for nearly all other diseases
have the opposite issue of having disproportionately low numbers of people of color. The chapter
begins with the research questions, followed by an overview of the study methodology and
positionality statement of the researcher. Next, the data sources are described, including the
participants, instrumentation, data collection procedures, data analysis, and credibility and
trustworthiness. The chapter will end with a section on ethics and another on limitations and
delimitations of the study.
Research Questions
The purpose of this project was to explore the perceptions of clinical trial staff, who are
responsible for identifying and recruiting clinical trial participants, about the reasons leading to a
disproportionate number of Black individuals participating in schizophrenia clinical trials.
Additionally, understanding the recruitment practices and challenges provided additional insights
in addressing why this phenomenon is seen. Using a qualitative approach of interviews combined
with artifact analysis, this study examined the following questions:
1. What are the perceptions of clinical trial staff about the factors leading to the
disproportionate representation of Black patients in schizophrenia clinical trials?
2. What are the practices of clinical trial staff in recruiting patients into schizophrenia
clinical trials?
60
3. What are the challenges and barriers in recruiting a racially representative sample in
schizophrenia clinical trials?
Overview of Design
This study was a qualitative study, with multiple sources of data collected (Creswell &
Creswell, 2018). Information was primarily drawn from participant interviews supplemented
with artifact analysis. As the focus of the study was on the rates of participation of Black
individuals in schizophrenia clinical trials, the roles within the trial ecosystem that are
responsible for identifying and recruiting potential participants were the source of the interviews.
Additionally, as awareness about clinical trials is often raised to potential participants and their
families or treatment providers through advertisements in various media or direct
communications, these recruitment materials will comprise the artifacts that will also be
analyzed. Table 1 lists each research question and whether the findings were generated from the
interviews, artifact analysis, or both.

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Table 1
Data Sources
Research questions Interview Artifact analysis
RQ1: What are the perceptions of clinical trial
staff about the factors leading to the
disproportionate representation of Black
patients in schizophrenia clinical trials?
X
RQ2: What are the practices of clinical trial
staff in recruiting patients into schizophrenia
clinical trials?
X X
RQ3: What are the challenges and barriers in
recruiting a racially representative sample in
schizophrenia clinical trials?
X

Research Setting
The research setting for this study was pharmaceutical research and development,
specifically, the ecosystem that conducts psychiatric clinical trials. This organization is complex,
as it is not a single business entity but rather multiple components that includes pharmaceutical
companies, principal investigators and staff, and the individuals who participate in the trials. The
pharmaceutical companies are the sponsors of the clinical trials of interest in this study, as they
generally own and are responsible for developing the compound that is being studied in these
trials. Principal investigators, often physicians, are contracted by the sponsor company to
conduct the trial. These investigators work at clinical trial sites that can be located at hospitals,
62
academic institutions, or outpatient clinics, with a research staff who are responsible to execute
the trials. Lastly, the individuals in the trials are patients who voluntarily agree to participate.
There are other components to this ecosystem, including hospitals and vendors who are
contractually delegated task performance on behalf of the sponsor, though they are not in scope
for this study. The participants in this study will be the research staff at the sites who execute
psychiatric clinical trials as they are closest to the patient identification and recruitment
activities.
The Researcher
My positionality is as a White clinical trial professional who has worked in psychiatry for
most of my 27 years of experience in my field. I have held positions similar to those of the
participants in my study for the first five years of my career and have personal experience with
executing psychiatric clinical trials at research sites, including patient recruitment activities for
schizophrenia clinical trials. I recognize that this experience may bias how I interpreted my
findings though I was committed to awareness of these biases. I am additionally reminded that
my experience is from over two decades ago and losing its relevance with the passing of time.
For the last 22 years, I have worked in research and development at pharmaceutical companies
who are the sponsors of clinical trials, though some of that time was in other disease areas
besides psychiatry, which gave me insights in how clinical trials are executed in oncology and
virology. Currently, my role is to lead the development operations teams for several products at a
pharmaceutical company that develops and markets multiple treatments for mental illness. This
positionality may also have biased the interpretation of my findings as I have been influenced for
many years by the sponsor’s needs from cl inical trials.
63
Also, I am not a person of color, but a White woman who is interested in helping to
dismantle the effects of systemic racism. My desire was to focus my research on an area within
my professional field that might allow me to have an impact to this effect. The aspiration to
dismantle components of systemic racism may also have led to biases in how I viewed and
interpreted my data. Further, I do not live with a serious mental illness. I recognize that I do not
understand the lived experiences of Black individuals, nor will I know the influences involved in
making decisions regarding treatment for serious mental illness, though I understand the added
complexities that this intersectionality brings. These aspects of my positionality put me in a
position of power over the individuals with schizophrenia who are being recruited to clinical
trials, so I worked to have adequate engagement with my data collection and tried to identify
evidence that did not support my preconceived explanations (Merriam & Tisdell, 2016). Along
these lines, I designed this study carefully in order not to get caught up in the ethical dilemma of
the researcher as an exploiter (Glesne, 2011), as this was one of the biggest concerns I had in
terms of my positionality with addressing this problem. Additionally, having engaged in a
thoughtful reflection upon completion of the study also helped to mitigate these biases.
Data Sources
There were two data sources for this study, interviews and artifact analysis. The primary
source of data for this study was participant interviews with individuals who have experience
conducting and recruiting schizophrenia clinical trials at research sites. This data was
triangulated using artifact analysis of patient recruitment materials that were gathered from
clinical trial offices or through online searches.
Interviews
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The interviews were the primary data sources for this study. The interviews were semi-
structured, as the list of questions and possible probes was created and referenced during the
interview, though there was flexibility in how the questions were administered based on the flow
of the conversations with the participants (Merriam & Tisdell, 2016). This approach guided the
conversation yet allowed for understanding of the participant’s wor ldview and possible new
thoughts on the issue. Zoom was utilized to conduct the interviews in an online setting.
Participants
The participants in the interviews were current clinical trial staff in roles such as study
coordinator or recruitment specialist at sites who have experience conducting schizophrenia
clinical trials. One participant had less than a year of experience, though all of the others had
over 5 years of experience working in clinical trials. The participants have been involved in the
subject identification and patient recruitment activities for these trials, and also had experience
with clinical trials for other conditions as well, though two of the participants had predominantly
schizophrenia experience. Some of the participants had worked for many years in clinical trials
and have held multiple positions at clinical trial sites, though currently had leadership roles at the
sites rather than positions specific to coordination or recruitment. As their current roles still were
related to patient recruitment activities, and their experience was extensive, they were deemed
eligible to participate. Any potential participant who had directly worked with the researcher in
previous business interactions were excluded from participation to minimize a potential conflict
of interest.
Approximately 15 participants were planned to be interviewed, though due to recruitment
challenges, 12 interviews were successfully completed. Recruitment for the participants had
evolved during the conduct of the study as a result of the challenges. The initial plan was to
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request professional organizations with which clinical trial site staff are affiliated, such as
Society for Clinical Research Sites, to email their members with information about the study.
Though this organization did send the email, no one responded with an interest to participate.
The recruitment plan was later revised to include social media and snowball recruitment. A
recruitment ad was created and posted to LinkedIn, and the researcher shared the ad via the
LinkedIn messaging feature with multiple individuals who work in clinical trials. The same ad
was posted to clinical trial professionals groups on Facebook as well. Additionally, snowball
recruitment from individuals connected on social media in addition to previous interview
participants was used, and individuals were asked to share the recruitment ad with others who
may be interested. The recruitment ad included a link for interested individuals to schedule an
interview directly with the researcher. Efforts were made to recruit participants from both a
variety of clinical trial site types, including academic institutions and freestanding clinical trial
offices, and geographic locations throughout the U.S., including urban and suburban settings.
However, the realities of recruiting required the researcher to accept all individuals who were
deemed appropriate to participate, regardless of location or site type. At the completion of the
interview the participants were offered a choice between a $25 Amazon gift card or a $25
donation to the National Alliance on Mental Illness. This offer of compensation was deemed
necessary to recruit enough participants as there was no perceived benefit to the individual for
being interviewed, though it took approximately an hour of their time. It was additionally noted
on the recruitment ad in order to help attract interested participants. This compensation was self-
funded by the researcher.
It was anticipated that not every respondent would be appropriate to participate in the
interview, so additional interviews were expected to be scheduled beyond those that were
66
successfully completed. Indeed, two interviews were completed and a third was started with
individuals who did not appear to have had experience with clinical trials, though this was only
suspected during the conduct of the second of these three interviews. It became apparent that the
second individual was connected with the first individual as the responses were very similar and
the knowledge about schizophrenia or clinical trials was equally very low. Additionally, other
aspects were suspiciously similar, including when the interviews were scheduled and the email
addresses that were used to schedule the interviews. Another 11 similar interviews were
scheduled, though they were immediately terminated once it was determined that they were
connected with the original three non-qualified participants. It is suspected that a group of people
saw the recruitment ad on social media and were attracted to the potential for compensation. As
the first of these three interviews had at least part of the interview conducted and the transcript
was recorded, they were assigned participant numbers. However, the data from these interviews
was not considered in the analysis. This led to a gap in the sequencing of the participant
numbers.
Instrumentation
The instrumentation was an interview guide to ensure the same basic questions were
asked for each participant (Patton, 2002). This allowed for the best use of the interview time, as
the questions were both focused though allowed for the participant to provide details in their
responses. The interviewer approached the interview as a conversation with the participant and
flexibly used the various questions and probes to guide the interview, while adapting the
wording, order, or the topic as needed. The interviews were conducted over Zoom.
There were 15 questions written in the interview guide, and each question had additional
possible probes. The questions and possible probes are included in Appendix A. Probes are
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important to elucidate more details from the interviewee, and it was helpful to have these pre-
identified in the guide (Bogdan & Biklen, 2007). Each question was related to the clinical trial
process to understand the factors that may be unique to schizophrenia or the patients that are
recruited, or about the influence of racism in the services and options the potential research
subjects have access to, though the latter was assessed indirectly to minimize bias of responses.
These types of questions were intended to uncover nuances in how research patients are
identified and were intended to show the reasons why schizophrenia studies recruit an
overrepresentation of Black individuals. Additionally, the questions were asked in an open-ended
manner to allow the full range of possible responses from the participants (Patton, 2002).
Data Collection Procedures
The data was collected through interviews conducted over Zoom, which were scheduled
by the participants at a time that is convenient for them and the interviewer. Utilizing Zoom
allowed for flexibility of participation of individuals located across the U.S., as well as
permitting them to choose their location during the session, which allowed the interviewees to be
more open with their responses as some participated from their homes rather than their
workplaces (Weiss, 1994). Each interview was expected to take up to an hour, and this
expectation was explained when scheduling the session in the online calendar. The actual
sessions lasted between 40 and 60 minutes. Following the explicit consent of the participant, the
interview was recorded and saved to facilitate data analysis, and an automatic transcript was
generated by the Zoom system. The recordings and transcripts were stored on a password
protected computer to which only the researcher had access. The participants were informed that
the saved files would be destroyed upon completion of the dissertation. The interviewer also took
handwritten notes during the interview to mitigate any risk from technological failure in the
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recording. For one interview, the recording did not generate a transcript. The transcript for that
interview was generated from the saved audio file through Otter.ai, another system that creates
transcripts. For added protection, the participants also had the option to change or hide their
Zoom name, though none opted to do so. Importantly, the participants were instructed not to
share any proprietary information about clinical trials with which they have experience,
including the name of the sponsor or investigational drug, as those details were not relevant to
the topic. The focus of the interview was limited to their experiences of patient recruitment
practices, and this message was reinforced during the interviews.
Data Analysis
The data from the interviews were analyzed qualitatively using the research questions and
conceptual framework of the study. The data analysis began with a review of the automatically
generated transcript in comparison with the recording to ensure no major gaps or lack of clarity
which would require follow-up with the participant (Patton, 2002). An extensive clean up of each
transcript occurred to ensure accuracy of the content. This was completed as close as possible to
the completion of the interview, generally the same day, to minimize any loss of details with the
passage of time. Concurrently, this was a time of reflection upon the interview to ensure quality
of the data collected and a general familiarization of the information stated.
Next, the transcribed content of each interview was coded with the assistance of the
Atlas.ti software program and then grouped into categories with similar findings from the other
interviews (Merriam & Tisdell, 2016). The coding occurred over multiple rounds, and each
interview was completely reviewed a minimum of two times. The specific categories were open
and defined after reviewing the initial interview transcripts though were created with the research
questions and conceptual framework in mind. Many edits and changes were made to the coding
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to ensure consistency in the definitions and use of each team. The codes were eventually sorted
into categories and hierarchies until the themes emerged and the classifications appeared final.
Artifact Analysis
Artifacts related to the identification and recruitment of potential participants in
schizophrenia clinical trials were also analyzed to support the interpretation of the findings from
the interviews. Artifacts are useful as they naturally exist in the environment that is being studied
and analyzing them has minimal impact on the participants or the subject of study (Merriam &
Tisdell, 2016). The artifacts that were gathered for this study were physical materials used to
raise awareness about schizophrenia clinical trials such as social media advertisements and
websites in addition to physical materials such as recruitment brochures and posters.
Data Collection Procedures
The artifacts for this study were collected through two primary mechanisms. The first
were searches for information about schizophrenia clinical trials by the researcher on the internet
and social media. This resulted in finding three study websites for schizophrenia clinical trials.
Two social media advertisements later were found in Instagram Stories, likely as a result of both
searching online for schizophrenia clinical trials and being within a close location to a clinical
trial site conducting a trial. The researcher also had the opportunity to look for hard copy
recruitment materials, such as flyers, posters, or brochures, while visiting clinical trials for a
separate, non-study purpose. Sites generally have waiting rooms, like most doctors’ offices,
where these materials are displayed. This resulted in collecting 7 brochures and 1 poster.
Advertisements and documents only for currently enrolling schizophrenia clinical trials were
found, which was to be expected, as recruitment materials for completed clinical trials are
normally destroyed as they are no longer of use. Regardless of the source of the artifact
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collection, each item was assessed for its authenticity, including determining the creator of the
artifact and the timeframe when it was used (Merriam & Tisdell, 2016). Additionally, artifacts
located online were examined closely to determine authenticity before deciding to include them
in the data analysis. Lastly, the research had intended to collect records of traditional media
advertising, such as advertisements on public transportation, radio, newspaper, and television.
Though no robust searching was specially conducted, attention was paid to these media though
no schizophrenia clinical trial advertisements were found during the conduct of the study.
Data Analysis
The artifacts were analyzed using content analysis of the items, specifically looking at the
nature of the artifact itself as well as the specific wording (Merriam & Tisdell, 2016). The overall
messaging in these documents was evaluated, such as if there is any referencing or targeting of
any specific group of potential participants, such as by race, ethnicity, socioeconomic status, or
living situation, or whether statements in the materials would attract a particular type of potential
participant. The findings were categorized into the same themes that were identified for the
interviews, and this was used to triangulate those findings.
Validity and Reliability
As a qualitative study, at least three specific activities occurred to ensure credibility and
trustworthiness. The first one was adequate engagement in data collection, specifically to look
for evidence that may support a different explanation (Merriam & Tisdell, 2016). All responses
were considered separately and not automatically assumed to support the proposed explanation.
Additionally, it was explored whether any responses possibly rule out the original presumption.
Secondly, the researcher engaged in positionality to identify biases and assumptions, and what
impact that may have on the data. Lastly, the documentation of this study in this document
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served as an audit trail that documented the process for the conduct of the research. Though
some changes occurred with the plan to conduct this study, those were identified in the final
writing. The first item addressed credibility, the third item addressed trustworthiness, and the
second item addressed both. Two other mechanisms to support credibility and trustworthiness
that were built into the study methodology were triangulation and member checks. The inclusion
of the artifact analysis was to triangulate the interview, during which the interviewer summarized
or paraphrased responses from the participant as a member check for accuracy.
Ethics
The ethics of the study were critically important to maintain. Black individuals with
schizophrenia could be harmed if the research resulted in actions that take away a potential
treatment option that currently fills a need. Additionally, though the Black clinical trial
participants with schizophrenia are centered in the conceptual framework of this study, the
perspectives that were collected were those of the researchers who recruit these individuals into
clinical trials. As systemic issues, rather than the patients themselves, may be the cause of the
racial imbalance in trials, the clinical trial researchers may be better suited to provide insight and
were the reason they were chosen for the interviews. Lastly, this study served the interest of
those who are concerned about the ethics of race and medical research, as well as those who
were working towards racially diverse and balanced clinical trial data. If appropriately
conducted, the patients with schizophrenia will ultimately benefit as well, as more representative
data can be generated for the treatments being developed, and additional safeguards preventing
specific groups from being targeted for research could be put in place.
Prior to engaging in any participant recruitment or data collection activities for this study,
the protocol and supporting tools were reviewed and approved by the University of Southern
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California (USC) IRB. IRBs review research studies to ensure protection of human subjects and
ethical conduct of the study (Creswell & Creswell, 2018). Only after receipt of IRB approval did
activities related to this study begin, including the recruitment of participants.
Though an information sheet was originally prepared and intended to be used to obtain
consent of the participants, the IRB did not require its use. Rather, during the introduction to the
interview, before the recording started, the researcher informed the participants of the
background and purpose of the study along with the expectations of the interview. The
participants were directly asked whether they provided verbal consent for recording the interview
and were informed that the recording and transcript would be destroyed upon completion of the
dissertation. Lastly, the participants were told that no identifying information about them will be
retained, and that each participant was only identified using a study identification number, such
as P01 for the first participant.
As the participants may have been employees of institutions or organizations who
previously were or currently were under contract with the employer of the researcher during the
conduct of the study, additional care was taken to minimize any potential conflict of interest.
First, the researcher’s concurrent status as a USC student and employee at a specific
pharmaceutical company was disclosed. Second, it was stressed to the participants that the study
was being conducted for a dissertation at USC and was separate from the researcher’s
employment, even though there was overlap in the content. Third, the fact that there was no
financial or other support from the pharmaceutical company in the conduct of the study was
stated. Fourth, if the researcher had previously directly worked with a potential participant in
conducting business, they were not permitted to participate to reduce any potential conflict of
interest. Fifth, the participants were reminded not to disclose any proprietary information about
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clinical trials, including not to mention the study sponsor or investigational product, to prevent
the accidental sharing of competitor information. Lastly, these plans were reviewed with the
Ethics and Compliance department at the researcher’s employer to ensure t ransparency about the
research intentions and no conflict of interest.

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Chapter 4: Findings
The purpose of this study was to explore the perceptions of clinical trial staff, who are
responsible for identifying and recruiting clinical trial participants, about the reasons leading to a
disproportionate number of Black individuals participating in schizophrenia clinical trials, along
with exploring recruitment practices and challenges. The study centered on the staff of the
clinical trials, as both are part of the societal system that has marginalized Black individuals.
Understanding how individuals with schizophrenia are recruited into trials can help explain why
Black individuals are overrepresented. In this chapter, I will describe the study participants and
will summarize the findings by each of the following research questions:
1. What are the perceptions of clinical trial staff about the factors leading to the
disproportionate representation of Black patients in schizophrenia clinical trials?
2. What are the practices of clinical trial staff in recruiting patients into schizophrenia
clinical trials?
3. What are the challenges and barriers in recruiting a racially representative sample in
schizophrenia clinical trials?
Participants
The participants in this study were twelve clinical trial site personnel who were
experienced in executing schizophrenia clinical trials. Each participant either currently or
previously held roles at sites in study coordination or patient recruitment. Numerous participants
have held multiple roles at sites over time, including site director or owner, though had previous
direct experience in coordination or recruitment to meet criteria for participation. All participants
had at least some experience with clinical trials in other psychiatric indications besides
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schizophrenia and were able to draw on those experiences to discuss potential similarities or
differences with schizophrenia clinical trials.
The participants were located throughout the United States, and most worked for
independently owned clinical trial sites. These are generally outpatient offices that are not part of
another entity, such as a hospital. Others worked at site networks, which are organizations that
own multiple clinical trial sites in different locations in the country, that centralize the business
functions of the sites. One participant worked at a community mental health center (CMHC).
Table 2 provides details about the participants, who are listed by participant number, current
role, and primary location and type of site where they work. Relevant previous role or location
are also included.

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Table 2
Participant Overview
Participant
number
Role Location Site type
P01 Recruitment manager Chicago, IL Independently owned
P02 Study coordinator Chicago, IL Independently owned
P03 Recruitment specialist Chicago, IL Independently owned
P07 Recruitment manager Las Vegas, NV Independently owned
P08 Site director (previously study
coordinator)
Phoenix, AZ (previously
Oceanside, CA)
Independently owned
P09 Site director (previously study
coordinator)
Miami, FL Site network
P10 Study coordinator Ft. Lauderdale, FL CMHC
P11 Site owner (previously study
coordinator)
Bellflower, CA and
Riverside, CA
Independently owned
P12 Patient advocacy lead
(previously recruitment
specialist)
Little Rock, AR Site network
P13 Study coordinator Monroe, LA Independently owned
P14 Project manager (previously
recruitment manager)
Atlanta, GA Site network
P15 Recruitment specialist Garden Grove, CA Independently owned
Note. Data collected from P04, P05, and P06 were eliminated from the analysis due to
participants not meeting criteria for participation.

Artifacts
In addition to interviews, an artifact analysis of schizophrenia clinical trial recruitment
material was also conducted. Four types of recruitment items were analyzed: brochures, posters,
social media posts, and clinical trial websites. The results of the analysis are incorporated in the
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analysis of the research questions below. Table 3 summarizes the artifact type, how many were
analyzed, and the method of finding of the artifacts.
Table 3
Artifacts Overview
Artifact type Number Method
Brochure 7 Found in waiting rooms of clinical trial offices
Poster 1 Found in waiting room of a clinical trial office
Study website 3 Online search for “schizophrenia clinical trial” and “new
treatment option for schizophrenia”
Social media post 2 Appeared in social media feed after conducting online search
for trials

The findings from this study are presented in the following sections, which are organized
by research question. The interviews addressed all three research questions, whereas the artifact
analysis provided insights to the second research question. Specific examples and quotations are
provided.
Research Question 1: What are the Perceptions of Clinical Trial Staff About the Factors
Leading to the Disproportionate Representation of Black Patients in Schizophrenia Clinical
Trials?
This research question directly addressed the main purpose of the study. During the
interview, the participants were asked several questions about their perceptions of the
motivations of individuals with schizophrenia to participate in clinical trials, including how they
learn about the trials and the types of questions they ask during the recruitment process. Later,
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the participants were directly asked to share their thoughts on why schizophrenia clinical trials
are overrepresented by Black individuals, whereas this phenomenon is not seen in other
psychiatric indications. The findings for this research question are categorized into four themes:
lack of access to resources, convenience, racial disparities, and location.
Lack of Access to Resources
All 12 participants noted that schizophrenia patients lack access to resources, which
influences their participation in clinical trials. Additionally, Black individuals were noted to have
greater challenges with accessing these resources. As discussed further below, the term
“resources” was used in this study to describe the following factors: 1) healthcare, 2) insurance,
3) psychiatric care, 4) adequate psychiatric treatment, 5) housing, 6) social support structure, and
7) money.
Clinical trials are used as a healthcare option due to the lack of access to healthcare.
When asked why patients with schizophrenia were motivated to participate in clinical trials, P07
stated: “Because the American healthcare system is a complete joke. It's a joke. We don't have
healthcare. We have symptom care. We don't have healthcare and mental health has historically,
across the board, been ignored.” Due to the absence of care, individuals seek out alternative
options for healthcare. P07 continued:
Clinical trials do offer an alternative form of healthcare. When they come in, we do a
very extensive prescreening process before patients are even enrolled, and then once
they're enrolled it's even more in-depth, so blood draws, urine screens, EEGs, EKGs. For
some studies that we've had for schizophrenia, we even partnered with an
ophthalmologist across the street, and they get their vision checked. If you think of like
regular, run of the mill [person] like me, when's the last time you had a full lab workup?
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And had an EKG and an EEG, and your vision checked for free? So that's an option for
them. And then additionally, we have the ability to prescribe, so most of the time it is
psychiatric medication. But other forms of medicine as well, things that can be
controlled, perhaps like hypertension.
Other participants presented similar explanations. P02 described the clinical trials offered at her
site as “a form of health care that they otherwise would not get outside of, or have difficulty
obtaining outside of, our network of our programs.” Lastly, P14 simply summarized it as “Again,
it's a great care option. Research is a care option.”
Schizophrenia patients are not able to access healthcare due to a lack of insurance. As
P09 stated, “if you don't have the ability to get insurance, you can 't get the treatment that you
need.” The schizophrenia clinical trial participants were described by P09 as having “the
inability to really access the care that's needed without having insurance and such.” Similarly,
P14 described the patients in trials by stating “they're underinsured or not insured. They're
underrepresented. They can't get into [hospital].”
The lack of insurance also limits access to psychiatric care, in addition to general
healthcare, and clinical trials additionally play a role in filling that gap. The study participants
provided examples of how schizophrenia clinical trials provide patients with alternative forms of
psychiatric care. P09 explained that “for individuals who may not have access to regular care,
participating in a clinical trial, if nothing else, can provide a fairly standard clinical care for a
certain amount of time because they're going to be meeting with psychiatrists.” P02 further
described the gap in psychiatric care that schizophrenia clinical trials fill as:
And the reality is with our healthcare system, especially mental health care system,
clinical trials end up being like a plan B or even just a different type of insurance, if you
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will, it's not insurance, but it's another form or opportunity for treatment that is hard to
come by elsewhere. If you don't have health insurance, or the reality of it could take six
months before you can get in to see a provider for the first time. So I feel there are
individuals who come in and use us to bridge the gap or an interim between, say they
were just hospitalized, but then they also need to get into standard of care. So this bridges
the gap between that setting and being able to get standard of care treatment elsewhere.
Similarly, P11 described statements made by schizophrenia patients when they reach out for
potential participation in clinical trials: “’I couldn't get in with my doctor. They didn't have time
for me. y next appointment is 3 months out. I'm out of my med.’ That struggles [sic] for real.
That's a definite, motivating factor.”
Inadequate or inconsistent psychiatric care commonly occurs for those patients with
schizophrenia who have access to healthcare though public aid, as indicated in the previous
quotes. Patients may receive some psychiatric services at neighborhood clinics or CMHCs,
though the services are limited, as P01 expressed “I think those clinics and doctors, they do the
best they can. … But when it comes to sc hizophrenia … they kind of fall through the cracks until
maybe they're hospitalized.” Similarly, P11 stated about schizophrenia patients that “ ost of
them lack consistent access.” Regarding the quality of psychiatric care the patients may receive
at the clinics or C HCs, P12 responded with “Are they adequate? Are they getting like good
quality, mental health care? No, no.” P09 provided more details about the limited care:
I would say it was pretty limited. It was just usually a medication refill, and not really
even assessing whether or not the medications were working or not working unless there
was some sort of complaint. y standard patient would tell me “ y doctor saw me for
5 min,” and you know they bill for an hour. But that is how that would work.
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The lack of adequate psychiatric care for those patients who have access to some care, was
described by participants, regardless of their location in the country.
Access to housing also appeared to be a factor that led to Black patients participating in
clinical trials. Some participants drew the connection between housing and the ability to stay
compliant with medications. P02 described:
So you have individuals with psychosis, or schizophrenia, in this case, where they're
supposed to take a pill every day, and to stay stable, or to help stay stable, even with
proper medication, you can still have acute exacerbations of your symptoms. But,
sometimes that's hard for people. It's hard for people to remember if they don't have the
other things in place, like appropriate housing, “Where am I going to sleep tonight?
Where's my next meal coming from?” Things like this. Do they really remember? That' s
the last thing they're gonna worry about is like, “Oh, I got to take my pill at nine o'clock”,
or whatever it is.
Lack of housing also played a role in the patients’ ability to access general healthcare and
psychiatric care. P09 described how this factors into the motivations for joining inpatient clinical
trials:
And for those patients who didn't have really much care at all, they'd be in and out of the
hospital. A lot of times it wasn't necessarily for acute exacerbations or anything like that.
It was a social situation. It was like, “I don't have somewhere to stay for the night. I'm
gonna go and say I'm hearing voices. And they're gonna put me in the hospital for a night,
and at least I'll have a bed, and a hot meal”, and then they would leave with a
prescription.
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P01 similarly stated that “the inpatient studies, that can be a blessing for the patient, especially if
they're struggling with housing.”
Lack of a social support structure, either through family or other social services, also
impacts why schizophrenia patients join clinical trials. Individuals with schizophrenia often lose
the connection with their families due to the challenges of the disease. P09 stated that “a lot of
times they've separated, so much due to the nature of the disorder, the distrust and paranoia, that
they don't have those people who are super close to them.” P10 similarly described schizophrenia
patients as “a lot of them have been estranged from the family. And so the family is not part of
their treatment.” Additionally, P12 explained that this estrangement can extend beyond the
family and into the community as well “by the time they're usually so symptomatic, they're
having so many struggles that they're in need of those type of services, and there's just a lack of
support in the community.” This lack of this social support leads to lack of compliance with
medications. P01 described of the individuals without social support networks who stop taking
their medications and become symptomatic: “if they don't have someone in their life to kind of
say, ‘listen, you gotta go to the doctor, you know this is not right’ then they might just end up on
the street.”
Finally, access to money impacts the ability to access care, insurance, and housing.
Clinical trials reimburse participants for their time and transportation cost. For patients with
schizophrenia, this reimbursement appears to be a major motivating factor to participate in a
clinical trial. All 12 participants stated the possibility of earning money, even if generally a
modest amount, was a factor. P11 stated “more than anything, I would say, it's the money,”
whereas P15 stated “The very first thing they're concerned with is how much money they're
going to make. That's a common response always. That's the very first thing.” P02 added “we'd
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be naive to think that it wasn't monetarily motivated.” P10 took the financial motivation a step
further with “We have a lot of people from different countries down here in South Florida that
don't have benefits. It's just a way of making money for people that can't hold a job or can't get a
job.” Interview participants were careful to state that even though the patients may have been
motivated by money, the clinical trial sites would not enroll them in studies if this was the only
motivator. P09 described it as:
Unfortunately, I do think in this particular indication they tend to be very monetarily
motivated which it was challenging at times, because there's times where we really
needed volunteers. But if we had someone who truly was just there to make some money,
we usually wouldn't put them in a trial, because it just wasn't, I didn't feel right. Talk
about exploitation.
Similarly, P13 said that their site tells the patients that “their time and travel is compensated for.
But this is definitely not something that we're trying to coerce them to participate in based on
payment alone. But the compensation is a pretty big deal for our patients.”
Convenience
The study participants also noted that convenience was a key factor influencing the
overrepresentation of Black individuals in schizophrenia clinical trials; ten of 12 participants
noted that Black individuals are the patients they most easily find when recruiting for trials.
Multiple participants stated that regardless of recruitment tactic, Black individuals are most
likely to respond to advertisements, seek out care options, or be referred to clinical trials though
the sites are not directly targeting this demographic with recruitment practices. However, the
participants were not able to explain why they observed this phenomenon, though agreed that
this exists. For example, with respect to recruiting participants, P01 stated “Because if what
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you're saying is that a lot of sites like ours are heavy towards the African American versus the
White American, then what is the real answer? Where are the White schizophrenics?” When
asked if they had any thoughts on why schizophrenia trials in the U.S. are overrepresented with
Black patients, P10 responded simply “Hmm. No, I don’t.” When asked abou t the racial
breakdown of the schizophrenia trials at their site, P11 stated “We have a lot of Black males, a
lot, for whatever reason, I'm not sure.” Another participant, P09, offered a perspective that
highlighted this situation that is unique to schizophrenia, and one that appears to be deeply fixed
“So I wish I knew what that magic answer was, and I think that schizophrenia is going to be one
of the most challenging indications to reach that racial equity in participation.”
The participants discussed that their recruitment tactics are not designed to target
individuals by race, so specific targeting of Black individuals to participate in schizophrenia
clinical trials was not occurring from their perspective. P08 most clearly stated this idea:
I'm thinking about all the patients we had on the trials in both locations. And yeah, a
majority of them are African American. And no, I mean, I don't know why that is. I mean
at both locations, we have had other ethnicities join the trials and stuff too, but it's not
like we're targeting any type of certain demographic. … I mean, we're doing advertising
the same. You know that we do advertising to anyone. They were mostly from online
sources, like different campaigns.
Additionally, many participants noted that targeting recruitment efforts by race would be
difficult, further supporting the notion that focusing recruitment efforts on a particular racial
group would require intentionality. P03 stated “I'm just wondering how do you target specific
races?” and “I'm ju st curious how one would even go about that. They respond to an ad.”
Similarly, P08 pondered how someone would turn down a patient who responded to a clinical
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trial advertisement with: “I don't know what the conversation would go like with patients ‘Oh,
well, that's your ethnicity, you know you're not going to be eligible for this trial.’ How do you
say that to someone without them getting upset?”
Some of the participants questioned whether there is a difference in the prevalence rates
of schizophrenia between racial groups and if that explains the overrepresentation in clinical
trials. In a continuation of a quote noted above, P01 said “Where are the white schizophrenics?
Or, are there less of them? I mean I don't think there's any census on all that. So, yeah, it's a
question that I ponder myself.” Similarly, P14 stated “I've also thought : does schizophrenia
affect African Americans and is in greater prevalence in African Americans than it is Caucasians
or Latinos? I don't know the answer to that. I wish I did.” When asked why schizophrenia trials
are different than other psychiatric indications, P13 stated “I think the prevalence is definitely the
main factor. That would be my best guess.”
Racial Disparities
Racial disparities, either specific or systemic, also leads to the disproportionate
representation of Black patients in schizophrenia clinical trials. Of the eight participants who
provided support for this theme, five noted that disparities were systemic in nature. The response
from P02 to the question on her thoughts about the reasons for the overrepresentation of Black
patients in schizophrenia clinical trials was:
Systemic racism. In the way our systems and our structures are set up. I mean, that's
primarily it. I'm sure there's many other factors. But you know, White individuals, or
non-Black individuals, usually have the means or the methods because the system has
allowed that. We typically have insurance, we typically have providers, we typically have
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access to all of these things. Whereas systemically it's set up that Black or brown
individuals just don't and so, they're left to these finding other means.
Other participants did not directly use the term systemic racism, but adjacent terms such
as systemic oppression, systemic issue, and society. P03 noted “All of the barriers that we just
mentioned could also be systemic issues as well, just inequity all around, and lack of money and
support towards mental health issues.” Additionally, P07 explained that for Black indi viduals,
“every single institution that exists in the United States, they are systemically oppressed in
housing, they are systemically oppressed in healthcare, they are systemically oppressed in
education, and they are systemically and unfairly targeted by the legal justice system.” Similarly,
P01 stated “I think it's a lot of reasons, but I think it's society.” In explaining the need for early
and consistent treatment upon the onset of schizophrenia symptoms, he continued:
But you look at who's gonna get those services, someone with money and great health
insurance. For someone without, and I think that a lot of times, unfortunately in this
country it's also divided racially. … So I guess my bottom line is, I think it's society.
What's available to what people? At what time? As far as treatments services and support.
Lastly, P09 summarized this issue with “I think our country is a little messy. It's just inequity
across the board with everything. There's such a high level of racial disparity in in really every
kind of field.”
The disparities in the diagnosis of schizophrenia in Black individuals additionally drove
the overrepresentation in trials. P12 stated “Black males are two and a half times more likely to
be diagnosed with schizophrenia. … When people a re first reaching out for any help the
diagnosis is disproportionately given to some minority communities.” The disparities in
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diagnosis were sometimes paired with other disparities, such as in the criminal justice system.
P15 provided details:
I think that the disparity exists because of the prison systems. I think that there is an
overabundance of African American individuals that are incarcerated. I mean, I don't
think that, I know that, we know that, that is data that can be shown anywhere. We
incarcerate Black individuals at disproportionate rates to any other ethnicity for longer
periods of time. And we find that a lot of our patients are diagnosed in prison. And I think
that they want them medicated. I think they don't want to deal with the frustration, the
anger, the irritation, that these patients, that these prisoners, are having in such a broken
system, and I think that they over medicate them to keep them quiet, and then they teach
them what to say, as far as symptoms are concerned, so that when they leave, they can
stay in the system and they get on social security and they are medicated sheep.
Lastly, P07 described the disparities of how some schizophrenia patients end up in the criminal
justice system: “Black Americans with schizophrenia, they get diagnosed later in life. They don't
get diagnosed as early. They may have had symptoms and where did their symptoms end up?
Oh, they got landed in jail.”
Location
The location of clinical trial sites is a factor in the overrepresentation of Black patients in
schizophrenia clinical trials, and seven of 12 participants provided comments supporting this
idea. Some participants discussed their personal experience related to the location of their site as
compared to their perception of the racial breakdown of their community. The responses were
sometimes absolute in making the connection between the local area and the patient
demographics, such as P14 stating “I'm in Atlanta, so majority of our patients with schizop hrenia
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that we see in trials are African American.” P10 similarly stated “Here at the site, the area that
we live in is probably mostly African American, lower income. We provide free services to our
edicaid provider, too.” Other responses we more uncerta in. Due to gentrification changing the
demographics of the neighborhood where the site is located, P02 stated “But we're still an urban
city, so we still have the demographics of what a typical urban city would look like as well. So
yes, in a way, yes, we are representative of what the city population is.”
Other participants speculated on the racial demographics of the locations of other clinical
trial sites as the explanation for the participation rates. P12 explained it in detail:
So, in the United States, there is somewhere between 15 to 30 go-to sites, and a lot of
them are placed in California. A lot of them are in Florida, South Florida. There's some in
New York, and in those areas, if you look at the breakdown of the population, it
shouldn’t be really surprising, because if you break that population down a little bit
further, not just by racial background, but you look at that racial background based on
their economic status, especially like Atlanta. I mean the three big psychiatric sites that
everybody wants to use are there. And the population has what, 40 to 55% African
American and Blacks. … But you know, even in California, especially in the LA Basin,
where there's a big concentration of sites, that's really the case.
Though the actual racial demographics of cities may not match the speculations of the
participants, the physical locations of sites are a factor in the clinical trial participation rates.
In summary, the clinical trial staff provided responses that aligned with several key
explanations for the reasons Black patients were overrepresented in schizophrenia clinical trials.
Of the four themes, the first one, lack of access to resources, was noted by each participant, as all
provided responses describing how Black patients with schizophrenia lack access to healthcare
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or adequate psychiatric care, among other resources like insurance and money, which leads them
to utilize clinical trials as a care options. Each of the three remaining themes, convenience, racial
disparities, and location were endorsed by at least a majority of the participants. Systemically
created disparities not only have led to a lack of access to resources but also to Black patients
being more convenient to recruit for clinical trials.
Research Question 2: What are the Practices of Clinical Trial Staff in Recruiting Patients
Into Schizophrenia Clinical Trials?
The second research question aimed to learn about the various recruitment practices of
sites for schizophrenia clinical trials to understand if anything unique occurs for this indication
that may explain the overrepresentation of Black patients. The interview participants were asked
questions specific to schizophrenia studies about how recruitment plans for trials are created,
what a typical recruitment plan contains, and what the most successful strategy is. Some follow-
up questions were asked about their responses compared with other indications to explore
whether unique practices were used in schizophrenia.
The main finding for this research question was that schizophrenia trials are recruited
using a similarly customized recruitment approach. This means that all clinical trials implement
similar recruitment strategies, but the details are customized for the patient population being
recruited. The same appears to be true for schizophrenia clinical trials. Though the specific
practices that were successful for some sites may not have worked as well for other sites, the
overall concepts were similar.
Similarly Customized Recruitment
Clinical trials recruit participants though activities that are customized to the types of
patients being recruited and schizophrenia trials do not appear to be different, as all 12 interview
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participants shared examples that supported this idea. P08 described that the decisions about the
recruitment approach were specific for each study as “it just depends on the indication what's
going to be most successful.” P10 similarly stated “It's totally dependent on the study.” An
example of this customization was shared by P12, who described the differences between
recruitment for post-operative pain management trials and schizophrenia trials:
And we have noticed that if we put generally, let's say, 100% of a budget for all of our
post op, we may do 10% outreach and 90% general advertising, but that is completely
flipped whenever we look at schizophrenia research. We generally do 90% of community
outreach, and then 10% of general advertising. And the reason being is how individuals
may be getting their information. A lot of times if they are in a treatment facility, or
maybe a long-term care, or how they receive information, is a little bit different. We have
to get on the front lines, and we have to get to providers. We have to get to social support
network community organizations. We need to go to hospitals. We need to go to ERs. We
try to find touch points for individuals with schizophrenia where generally they’re part of
our community.
P08 shared the differences in how clinical trials were introduced to schizophrenia patients versus
those with depression “I have to really get into the study a little bit differently with the
schizophrenia population than I do with of the depression population, and it kind of depends on
their symptoms. Sometimes they might be very distrusting.” P08 additionally explained the
differences in response rates they see to various types of study advertisements because of the
disorder, such as that schizophrenia patients do not “click on the ads that we po st in social media,
that are so easy with depression and those other conditions. We find that the schizophrenia
population don't do that very much, not in comparison.”
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The participants also shared many examples of how schizophrenia recruitment is similar
to other indications. P03 stated “I personally have not had any difference in my recruiting for
schizophrenia compared to other mental health disorders.” P07 explained t hat “Social media
does tend to be the primary source of referral leads. So people that see the ad and that are
interested.” Several indicated that schizophrenia recruitment is trending towards being less
different from other indications, as mentioned by P02:
I've seen a change, a shift in the over the seven years. I think it used to be much more
different, much more separated with schizophrenia. There would be a lot of recruitment
either directly from the hospitals, or some sort of whatever programming that they were
in, or if they were seeing a different physician, or psychiatrist referrals in that way. But
now, we see since they have more means and more and more access than what they used
to. So for example, like the government provides phones to a lot of these individuals, if
they're on disability, for example, so many of these people have access to the internet,
just like we do, just like any other indication. And a lot of them have their own Facebook,
their own Instagram. So I think a lot of that has shifted over the seven years. And I think
advertising through social media platforms and email blasts and things like that are just as
effective in the schizophrenia population as it is any other indication, but it used to not be
that way. But I think it's moving that way.
P01 had a similar response, stating that schizophrenia is “not as different anymore that it's more
focused on social media.”
The actual recruitment practices used by the clinical trial sites were described by the
participants and are summarized below. They have been arranged into three categories: patient
recruitment through advertising, patient recruitment through networking, and patient-focused
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recruitment. Additionally, the artifact analysis helped to corroborate some of the responses
provided by the participants and are also included below where applicable.
Patient Recruitment Through Advertising
All 12 interview participants provided examples of using advertising to recruit
participants into schizophrenia clinical trials. Social media advertising was frequently mentioned,
with P07 stating “Usually we do stick to social media platforms as that tends to be the most
responsive” and later “Facebook is pretty popular.” Instagram and Facebook were frequently
mentioned as preferred platforms for the advertisements. P15 responded with “we do
advertisements on social media, Instagram and Facebook ads,” and P01 with “Facebook,
Instagram,” when both were asked where ads were placed. Social media appears to be the most
successful advertising medium for several sites, which explains why it is frequently used, and
other platforms beyond Facebook and Instagram are being explored. P07 detailed:
Social media definitely works because most people have social media, right? So some
form of Instagram or Facebook. We are trying to get a Tik Tok and Snapchat
advertisement. That's still in the works with our marketing team. That’s something I
suggested because a lot of people use Tik Tok, and people on Tik Tok express different
things, whether it's cooking videos, it's dog videos. But there is a significant portion of
Tik Tok users that talk very openly about their mental health issues. And younger people,
which schizophrenia, as we know normally doesn't start expressing symptoms until late
teens, early twenties. And those are the people that use social media platforms like Tik
Tok the most and discuss their symptoms. So if someone's not sure if maybe they're
having symptoms, but they've never received a diagnosis, I think that platform can be
helpful.
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Similarly, P08 commented that social media is their main form of advertising with “right now it's
mostly social media campaign. This is what's the most successful.” This reliance on social media
as a recruitment medium is consistent with other indications, as stated by P02: “I think
advertising through social media platforms and email blasts and things like that are just as
effective in the schizophrenia population as it is in any other indication.”
Traditional forms of advertising are also used for schizophrenia recruitment, such as
printed materials. P10 explained “There's been flyers, brochures, emails, … all kinds of ways.”
The printed materials often were created by the clinical trial sponsors and sent to the sites to
support recruitment. P01 stated they use “flyer s, posters, brochures. A lot of the sponsors still
will give us that information, you know, like they always did before.” P13 commented that these
items were easy to utilize as “we don't mind posting posters. You're putting the pamphlets out in
the waiting room.”
Television and radio advertising were mentioned by some participants. P15 commented
that for their “stable schizophrenia studies, we do advertisements on television. We do
advertisements on the radio,” and P01 also mentioned “there's other, radio o r TV ad placement.”
However, the use of these methods appears to be decreasing for all clinical trials, as P07
described:
We've tried different things like radio and TV, but no one listens to the radio anymore,
and most people don't watch television. Most people have streaming services. So unless
those ads are targeted to a specific streaming service platform like Hulu that has
commercials, those go unseen.
Several sites noted that they often use multiple advertising platforms, including social media and
other types of advertising, coordinated by the sites’ recruitment or marketing teams who
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specifically put together recruitment strategies that utilize the various media. P09 stated “our
marketing team would do digital ads, social media, print ads, things like that.” P12 described:
We have a central recruitment within the organization that helps with all of our different
trials. It consists of about 7 staff that help with everything from brochures, designs, social
media, and print media, really any type of advertising that needs to go out.
P07 described how the local recruitment team would advertise not just for a specific clinical trial,
but for an indication “We have our own internal advertisers that do digital marketing. They will
also place generic ads on social media platforms. So it might not be so study specific, but it will
be like a general schizophrenia clinical trial advertisement.”
Artifact Analysis
The analysis of the artifacts corroborated the comments the interview participants
provided. Social media ads, in the form of sponsored stories on Instagram, were found. The ads
simply stated “Experiencing acute schizophrenia symptoms? Delusions, hallucinations, jumbled
speech and thoughts. Learn more about an inpatient clinical trial for an investigational
medication,” with a “Learn ore” button to take them to a separate website. Only two ads were
found, likely explained by the fact that social media advertising is often geolocated, meaning that
individuals will only see the ads if they are in a location near one of the clinical trial sites.
Seven brochures and one poster were also analyzed as schizophrenia clinical trial
advertisements. These documents were collected in waiting rooms of clinical trial sites, where
similar handouts were also available for clinical trials in other disorders. All of these items
briefly explained the clinical trial and described the type of individual who may be appropriate.
The contact information for site personnel was included on only 25% these items, though each
had a space for that information to be added.
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The content of the artifacts supported a theme from the first research question, as all
documents had wording that would appeal to individuals who lack access to resources. Many of
the recruitment materials included statements that may attract individuals who were looking for
alternative healthcare options. One example is from OnlineAdvertising02:
Throughout the research study, your study doctor will perform several tests and
procedures, including but not limited to: recording medical history, conducting a physical
exam, measuring the vital signs, conducting a pregnancy test (if applicable), collecting
blood and urine samples.
Other examples of statements that would appeal to those who lack access to resources include
Brochure01 “Receive care from a local doctor at no cost to you,” Brochure03 “Enrolled patients
will receive all study-related procedures, medications, and laboratory services at no cost,” and
Brochure07 “All st udy-related visits, tests, and drugs will be provided at no cost.”
Additionally, each artifact included statements about a potential treatment option for
schizophrenia, which may appeal to individuals specifically seeking psychiatric care for this
condition. Examples include Poster01 “Researching an investigational medication for adults with
schizophrenia,” Brochure05 “If you or a loved one is living with schizophrenia and still
experiences symptoms while on treatment with antipsychotics, the Journey Study may be an
option,” Brochure04 “This study is testing the long -term effect of an investigational drug
(KarXT) for adults with schizophrenia. In this study, all participants will receive KarXT,”
Social edia01 and Social edia02 “Learn more about an inpatient clinical trial for an
investigational medication”, and OnlineAdvertising03: “These studies are evaluating the
effectiveness of the study drug, valbenazine, compared to placebo on symptoms of schizophrenia
including hallucinations and confused thoughts.”
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Lastly, several of the artifacts included statements of reimbursement for the trial
participants, which would appeal to the individuals who are lacking financial resources.
Examples include OnlineAdvertising01 “Reimbursement for reasonable, out -of-pocket expenses
for travel and accommodations may be available to qualified individuals,” Brochure06
“Reimbursement may be provided for study -related time and travel expenses,” and Brochure07
“Reimbursement for study -related time and travel may be provided.” Though the content of
recruitment materials varied, all of them included wording that would appeal to individuals who
are lacking access to resources.
Patient Recruitment Through Networking
Eleven of the 12 interview participants mentioned networking as an important form of
recruitment, the most common method being community outreach. P15 noted “we have our
community outreach that is out in the field talking about studies” and P14 described that this is a
successful strategy with “there's a lot of work done in the community. So I'd say that's probably
50% of it there as the referral sources.” The participants gave many examples of establishing
relationships in the community. P08 stated that the relationships develop “from over many years
of working with board and cares and different things to establish relationships with where they
live, and different members of the community to establish those relationships, and then get
patients to participate.” P12 explained that the connections take time to develop:
Even us as a site, sponsors are coming in, and they're saying, “what are you doing, why
are you not enrolling?” And we're like because it takes time. It takes time to build trust,
and it takes time to educate, and we need that time to build that trust with communities.
And so we're not going to do what you want us to do, and which is generally what we're
hearing from some of our communities, that helicopter research, we just got to fly into a
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community, “hey, I want you, need participants,” and then we fly back o ut. That is not
how we can approach this.
This community outreach work appears to be a newer activity for some of the sites, such as P09
who stated that this was added once they understood “that the regular, just standard marketing
wasn't cutting it anymore and boots on the ground out in the community doing education and
things was much more beneficial.”
Clinical trial personnel additionally contact individuals from their database of prior
participants and others who previously expressed interest in trials. This was noted by 11 of the
12 participants. P03 briefly stated “And then we, of course, have a database of people that have
come in and out of our facility for years, so we always reach out to them.” P08 described the
motivation for using the database as:
We always use our database first. We'll go through our database patients. We have a large
database of people that have previously signed up for clinical trials, and for one reason or
another, they either didn't end up participating, or maybe they did one, and they're not in
one right now. They might be interested in another one, so we'll go through that one in
the usual database.
P11 described the large size of their database with “We have a database that we have. We were
probably at 65,000 inquiries. So anybody who would inquire about a clinical trial online through
Google ads or on Facebook or Instagram, it would pull into our database.” P15 similarly
described how the database can grow over time “We have a very robust database. We've been a
site for about 20 years. So we do mass emails and mass text messages to recruit past patients or
anyone who has expressed interest in the past.”
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Lastly, some of the participants mentioned word of mouth as being a successful
networking recruitment strategy. P02 stated “it's a lot more word of mouth by people who have
been here with us and telling their friends who are in programs.” P14 added that “the other way
how these studies work is word of mouth, so they tell their friend, they tell them. And I think that
it's who they are with.” P11 commented that “It's still basically boils down a lot of the same
people who know you, word of mouth, people who have been in studies before, family members
reaching out to you.”
Patient-Focused Recruitment
All 12 interview participants described patient-focused recruitment activities such as
establishing rapport, education about clinical trials, and expectation setting. Most of these
activities occurred after potential clinical trial participants already expressed interest in a trial but
were deciding whether to participate. P12 explained the importance of establishing rapport and
trust with the patient:
A lot of times, the screening process is sometimes difficult, because sometimes talking
about their symptoms is not easy, and you have to meet the patient where they are at that
point within their symptoms and within their psychosis. So it's just very specialized. It
has to be very centered on that individual, that's the other thing too, this blanket type
approach does not work well with individuals. It takes that relationship.
P09 similarly described how building this rapport and human connection is important for patients
with schizophrenia:
I think the biggest thing that I was able to find with the outreach piece of it was just that
human connection. And given the nature of the disorder, being able to kind of earn that
trust a little bit helped significantly, in getting them comfortable to coming in, with the
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paranoia and such a lot of times. … But when you could go and meet face to face and
kind of explain what was going to go on, and why it was important, that helped build that
trust and rapport and led to more conversions to screenings.
Several other participants had similar comments. P02 stated “I know we do a very good job and
we pride ourselves on establishing rapport with people,” and P01 noted how their patients
“developed relationships, maybe professional relationships, with the study coordinators, the
doctors.”
Other ways that the participants described the patient-focused recruitment efforts was
education about clinical trials and their voluntary nature. P12 stated that they provide “general
education about clinical research or schizophrenia research” to the potential participants. P07
introduces clinical trials to interested participants by explaining “how we do phase testing and
say, you would be taking an investigational medication. That is how we conduct the trial. There
are other steps in the trial that you might have to participate in, different study procedures.” P09
described how they educated about the importance and trials by stating “an Advil or something
in the past have all had to go through this process to ensure that the drugs are safe and effective.”
P10 stated that patients “know that all studies are always voluntary. You can decide that you
don't want to participate upfront, or even if you consent, you can always withdraw from the
study. So they understand that.” P09 similarly added that they work to have the patients “truly
understand that it is all voluntary, and that if they were unhappy at any point, they could speak to
the doctor, the coordinator, and make a decision as to whether or not they wanted to continue.”
According to the study participants, potential clinical trial patients feel that they are
contributing to a greater good once they learn of the importance of clinical trials to the
contributions to science. P03 stated that some patients want “to really do good for people who
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also suffer from severe mental health issues like them and contribute to the good cause and
finding solutions for them.” P12 stated “Some are motivated by the fact they want to be a part of
this advancement of science.” This motivation to help others may be seen more recently, as
explained by P11 that patients seem to want “to help other people, like ‘I want to do this because
I know that clinical trials help other people.’ And again, that's really been boosted since Covid.
That wasn't quite much of a thing before.” Individuals with schizophrenia may be motivated to
participate in clinical trials from this perspective because they often do not have the opportunity
to feel valued, as P01 stated:
They feel like they're part of something important and big, and maybe in the rest of their
life they're not treated that way. They just don't have that. And so now they come in here,
and they feel important because they know they are important, because without them
there would be no research study. … I don't know what you term that, social aspect
maybe, or maybe just the feeling of importance, the feeling of something that you're
involved in. People don't see them always in the best light. And so they come here, and
they're treated like valuable participants in the research, which they are.
Other participants mentioned similar items, like P13 “I think it's from what we just talked about,
the social connection they feel,” and P14 “I think it's another reason why people with
schizophrenia do participate in trials. They get to be seen. They get to be heard.” P15
summarized this by stating “But these are human beings, and they crave socialization. … And
we are the only socialization they get.”
Lastly, clearly explaining the expectations of clinical trial participation and the study
medication occurs to support patient-focused recruitment. P07 simply stated “and I will always
too at the very end, explain the duration and study length, the amount of visits that they'll be
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expected to attend.” Explaining the trial expectations also meant discussing the potential of
receiving placebo. P09 described that they “explain the importance of placebo, and why it's
there, and that you know part of their participation in the trial is really to report to us anything
that they are experiencing throughout the trial as honestly as possible.” P02 detailed:
They also want to know if it's placebo controlled or not. “What's the likeliho od I'm going
to get the actual medication or the placebo? Who's going to know?” And then we have to
explain double blind, what that means. Is it open label, which means we know for sure
you're gonna get active medication, but then also telling them even though it is active
medication, we don't know if it's gonna work or not, you have to put that expectation, put
those expectations to rest, because that's why it's in research at this point. We don't even
know if it's even if it is active medication, we don't know if it's going to be effective.
P13 added that at their site they tell patients “we don't know if they're getting active drug. They
always want to know side effects and how severe are the possible side effects, so we'll go
through that with them.”
Artifact Analysis
The analysis of the artifacts showed that patient-focused messages are incorporated in the
recruitment materials, and many of the statements by the participants are corroborated by this
material. Six of the seven brochures and all three clinical trial websites had sections briefly
educating the reader about clinical trials. Brochure05 “Clinical research studies aim to answer
specific questions about how medicines work in the participants who take them.” Brochure01 “A
clinical trial is a type of research study designed to evaluate whether an investigational drug is
safe effective for use in humans.” Brochure07 “Pharmaceutical companies use research studies
to look at new ways to prevent, detect, or treat a condition or disease. Research studies are
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necessary to learn whether a new test or treatment works and is safe.” StudyWebsite03 “Placebos
are made of a substance that looks just like the study drug being tested, but they contain no
active ingredients.” StudyWebsite01 “A clinical study involves research usin g human volunteers
(also called participants) that is intended to add to medical knowledge.” The voluntary nature of
clinical trials was described as well in some of the artifacts. StudyWebsite03:
Participation in any clinical research study is completely voluntary, and participants may
choose to leave the study they enroll in at any time for any reason. If you would like to
leave the study, you should discuss this with your study doctor, who will give you
information about how to do this safely.
Brochure05 “Participation in any clinical research study is completely voluntary, and you may
withdraw from the study at any time for any reason.” Lastly, most of the artifacts (six brochures,
the poster, and all three study websites) described some aspect of the expectations of clinical trial
participation. Poster01 “Study participation will last for up to 9 weeks and will include up to 10
study visits. Participants will be hospitalized during the 6-week treatment period.” Brochure03
“You will take KarXT capsules tw ice per day for up to 52 weeks and your drug dosage may vary
based on your tolerability.” Brochure02 “Be randomly assigned with an equal chance to receive
either study drug or placebo. Come to the study clinic regularly to receive either study drug or
placebo and have health exams and procedures as per the study protocol.” StudyWebsite02:
Treatment: This period lasts approximately 14 weeks. Participants will be assigned at
random to receive either the investigational medication or the placebo and will take their
assigned study treatment once daily. This period includes visits to the study site for the
study team to check on a participant’s health.
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Lastly, Brochure07 “If you are eligible and agree to participate, you will be assigned by chance
to receive the investigational drug or placebo. You have an equal chance of receiving either
study drug (investigational or placebo).”
As mentioned earlier in this chapter, three clinical trial websites were analyzed for the
artifact analysis as well, though no participant mentioned the use of these websites in terms of a
recruitment tactic during the interviews. It is likely that the websites are the landing pages that
the other advertisements lead to, rather than being a standalone recruitment mechanism. Though
they play a role in recruitment for clinical trials, the clinical trial sites may not see them as a
means of driving recruitment for clinical trials.
In summary, the responses from the participants that addressed this research question led
to a single theme, similarly customized recruitment activities. Clinical trial recruitment is
commonly customized to match the patients with the indication that is being recruited, and this
appears to be the same approach used in schizophrenia. The participants described three main
categories of recruitment activities, such as advertising, networking, and patient-focused work.
The specific forms of recruitment do not appear to target a particular racial or ethnic group,
however, they do highlight the benefits of participation that may appeal to individuals who lack
access to resources.
Research Question 3: What are the Challenges and Barriers in Recruiting a Racially
Representative Sample in Schizophrenia Clinical Trials?
This research question focused on gaining the insights about the challenges that would be
faced if schizophrenia clinical trials were required to be racially representative of the population.
The research participants were directly asked to specify the challenges or barriers of enrolling
schizophrenia patients who are not Black into trials. Two themes emerged in the findings, access
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to resources and location, which will be further described below. The review of the artifacts did
not produce any support to answer this research question.
Access to Resources
Eleven of the 12 participants discussed that the biggest challenge to recruiting more non-
Black individuals would be that these individuals would not be motivated to participate in
clinical trials as they have access to resources. P01 stated that “most of them have continuous
care through a psych doctor or a local wellness clinic of some sort.” Similarly, P12 explained:
They may have a better support network of therapy services and then getting the
resources they need to help them with their symptoms, and they may be less inclined to
want to go into an experimental research study, because they already have the bandwidth
that they need for appropriate services.
This finding of access to resources is the opposite of what was identified for the first research
question, lack of access to resources. Whereas in in the first research question the factors for the
overrepresentation of Black patients was explored, this research question looked at a contrasting
view of the same problem, specifically what would be the challenges to have a more racially
balanced recruitment, so the relationship between the themes is not surprising.
Individuals who already are receiving adequate psychiatric care have little motivation to
change medications or to seek clinical trials as a care option. Additionally, it is not ethical to
remove patients from effective treatment solely for the purposes of entering a clinical trial,
unless there was a medically necessary reason. P02 described the thought processes of these
patients as “’Why should I do that? I have perfectly fine healthcare. I have perfectly fine
medication that’s working. I’m seeing a therapist every week. I’m seeing a psychiatrist once a
month. Why should I stop what I am doing?’” Similarly, P15 stated:
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White patients have more privatized health insurance, and they also have greater access
to private physicians and psychiatric care. ... So the challenge is that when an individual
is getting medical or psychiatric care from a private practice, they are less likely to a seek
treatment elsewhere.
Another example is from P07, who stated “White people have better access to healthcare, and
they have better access to mental healthcare. And they're stable. … And why would they?
There's no other reason than being generally interested in exploring a new therapeutic option.”
Individuals having access to social support structures is another challenge to recruiting a
racially representative sample in clinical trials. P09 described occasionally encountering patients
with “strong, familial support or strong social worker support tend to maybe not need as much
help, and don't necessarily seek out clinical trial participation, and for that reason tend to be more
stable, comfortable, have standard of care.” Later, P09 described that these individual “are
typically not the patients you put in the clinical trial, anyway, because you're not going to take
anyone who's stable and healthy on med, off to go into a clinical trial.” P15 framed the
connection between family support, being stable on medication, and more “stability” in their
lives as:
I think the challenge is going to be within the family system, and within the healthcare
system of the Caucasian individuals, because if stable, they have more stable lives, so
they don't want to disrupt that stability, or their family doesn't want that stability
disrupted, or their practitioner doesn't want that stability disrupted, and the Caucasian
individuals are just more likely to have that stability.
P01 put it another way “if you're 60 years old, but you're living with your sister out in the
suburbs, and she's monitoring your medication, it's much easier to stay on that medication,”
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meaning that the family support alone is a major reason patients remain stable on their
medication.
The possibility of receiving a placebo rather than an active treatment during the clinical
trial is another challenge to overcome for those individuals who have access to resources. As
many clinical trial designs in psychiatry require the use of a placebo as a comparator, patients
need to understand this possibility yet still agree to join the clinical trial. P02 stated the challenge
of needing “to get the people who have the means with mental health access to participate in
something that’s placebo controlled.” Additionally, P01 explained that other healthcare providers
are not willing to refer patients who already are receiving care because “they want to make sure
that patients can remain stable. And how do they know that, especially if it's a placebo-controlled
trial where they might be on a placebo?”
Location
The demographics of a site’s participants align s with the demographics of that site
location, which is the same finding as what was uncovered in the first research question where it
was noted that location of the clinical trial sites mattered. The study participants stated that
recruitment of a more representative sample into schizophrenia clinical trials would necessitate
for recruitment to occur further from the site location, with some of the participants in urban
locations stated that they would need to reach beyond the city borders. P01 stated “we might
have to expand our geographic range and focus more on the suburbs of the city.” P14 similarly
mentioned “It's just going to take a lot more effort at the site level to get more white people in
these studies with schizophrenia because they're gonna have to come from rural, outside of the
city.”
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Recruiting participants from a wider geographic location requires additional effort and
cost. P14 described possible shifts in tactics to reach the non-Black patients:
And it's gonna take more transportation, more advertising, more staff here to make that
possible. I mean, we will have to basically need 2 or 3 community outreach people than
now. But then you need more drivers. You need more vans, so it will take a lot. But we
can do it. It can happen. It's just gonna take more money.
The challenge of widening the reach of recruitment activities was summarized by P11, who
stated “I think oftentimes we don't go to those harder to reach places, because it's harder.”
In summary, the findings for the third research question, access to resources and location,
were related to some of the findings from the first research question. Whereas the lack of access
to resources and the locations of the clinical trial sites lead to Black patients being
overrepresented in schizophrenia clinical trials, the same line of thinking explains the challenges
of enrolling other racial groups into trials. The patients who have access to resources often are
more stable in their disease and are not seeking clinical trials as a care option, in addition to
living in areas that are not adjacent to the clinical trial sites.
Summary of Findings
This chapter summarized the findings of the interviews with 12 schizophrenia clinical
trial staff, along with the findings from the analysis of 13 patient recruitment artifacts, to explore
the perceptions of why Black individuals are overrepresented in schizophrenia clinical trials. Six
themes were identified: lack of access to resources, convenience, racial disparities, location,
similarly customized recruitment, and access to resources. The findings were presented by
research question, and quotes from the interviews and artifacts were provided throughout to
support the assertions.
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The data from this study indicate that Black individuals with schizophrenia struggle with
less access to resources which limits their access to consistent and adequate medical and
psychiatric care. Clinical trials have become care options for those individuals who live where
the clinical trial sites are located. The patient recruitment activities of the clinical trial sites are
not specifically targeting Black individuals, however the messaging appeals to individuals who
may be lacking other care options, and Black individuals are enrolled frequently as they are a
conveniently available sample. Individuals with more access to resources, such as White
patients, are less motivated to participate in research as they have access to adequate psychiatric
care where they live that allows them to maintain stability with their disorder. Chapter Five will
further discuss the findings and their alignment with the conceptual framework of the study, in
addition to suggesting recommendations for practice and future research.
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Chapter Five: Recommendations
In this study, I explored the perceptions of clinical trial staff on the reasons for the
overrepresentation of Black patients in schizophrenia clinical trials. I wanted to understand how
individuals with schizophrenia are recruited into trials to possibly explain why Black individuals
are overrepresented. In this chapter, I will connect the findings presented in Chapter Four with
the conceptual framework of the study and the literature on the topic. I will then present the
recommendations for practice derived the findings. Next, the limitations and delimitations of the
study will be summarized, along with recommendations for future research.
Discussion of Findings
The problem of practice for this study was systemic racism perpetuates non-
representative clinical trials in schizophrenia. By exploring the perceptions of the clinical trial
staff who recruit and identify the participants, several explanations were identified. Additionally,
understanding the current recruitment practices and potential challenges of adjusting them to
attract a different patient population helped explain the phenomenon of Black individuals being
overrepresented in schizophrenia clinical trials.
The findings from the study revealed that Black individuals with schizophrenia either
seek out or are more available for clinical trials due to their unequal access to healthcare and
quality psychiatric care. Clinical trials are seen as an alternative form of healthcare, with free
access to procedures, assessments, medications, and healthcare professionals, and those
individuals without access to care utilize trials to fill the gaps in their healthcare needs. Other
factors additionally contribute to the challenges in accessing care, including lack of insurance,
unstable housing, lack of a social support network, and overall low socioeconomic status. These
inequalities are the result of racial disparities that permeate all aspects of society from a
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structural level down to the individual. Additionally, the location of the clinical trial sites has an
impact, as the sites utilize convenience sampling for enrollment of those who live close enough
to attend in-person visits. The findings from the study also explain why it is challenging to
recruit non-Black patients into trials as these individuals are on the other side of the disparities
and are less likely to need an alternative form of healthcare. Lastly, regarding patient recruitment
activities, the clinical trial sites do not appear to be targeting Black schizophrenia patients for
recruitment into the trials, and similar recruitment methods are utilized as in other indications,
with appropriate customization for the disease. Advertisements, ranging from printed brochures
to social media, are used in addition to community networking and patient education.
Discussing the findings through the context of the conceptual framework can help to
further understand them. As described in Chapter 2, the conceptual framework for this study was
the ecological systems model (Bronfenbrenner, 1994) informed by critical race theory
(Solorzano & Yosso, 2001). The ecological systems model allows for the examination of the
interrelationship of the environment and the individual, whereas critical race theory
acknowledges the pervasiveness of racism and its impact. The following discussion will frame
the findings from the study in this conceptual lens as well as connect them to the literature. Of
note, the exosystem and chronosystem will not be discussed as the findings from the study did
not align in these layers. Though several of the study findings such as the lack of access to
resources and access to resources partially reside in the exosystem, they primarily occur within
the other ecological layers and are described in those. Additionally, as the interview questions
were worded to not lead the participants into drawing connections between current practices with
historical abuses, that may have unintentionally resulted in responses that were not related to the
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chronosystem. Therefore, the discussion will focus on the macrosystem, mesosystem, and
microsystem as the findings of the study reside in these layers.
Racial disparities are situated in the macrosystem, as these disparities initiate at the
systemic level and permeate each of the subsequent layers. Other studies in the literature have
similarly documented the impact of racial disparities across all ecological layers (Noursi et al.,
2021). Additionally, multiple studies have shown that systemic racism has created disparities in
all aspects of society, including impacts on health and psychiatric outcomes. For example, Jones
(2002) described how systemic racism led to reduced access to health care and lower quality of
care. Also, higher risks of psychiatric conditions and less access to mental healthcare have been
linked to systemic racial disparities (Kalin, 2021). Lastly, racial disparities at the systemic level
have been shown to be a reason for the overdiagnosis of Black individuals with schizophrenia
(Metzl & Roberts, 2014).
Further, the findings from the study indicated that systemic racial disparities create an
unfair environment with unequal access to services and resources. This includes challenges in
accessing healthcare in addition to quality and consistent psychiatric care, which in turn leads to
Black individuals either seeking care in trials or being more available to participate in them.
These findings are aligned with the literature, which shows that the healthcare system is not
equally resourced, leading to fewer healthcare facilities in minority communities (Bailey et al.,
2017). Additionally, stereotypes and biases within these systems lead to unequal experiences,
causing disparities in treatments and outcomes. For example, Lawson et al. (2015) found that
Black patients within the mental healthcare system are less likely to receive the effective and
safer second-generation atypical antipsychotics. Black patients are also more likely to be put into
physical restraints while receiving emergency psychiatric services (Smith et al., 2022). Other
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authors have described a cycle of fear in the mental healthcare system that also leads to poorer
outcomes (Keating & Robertson, 2004). The individuals with access to resources have different
experiences as they are on the other side of the racial disparities.
Lack of access to resources or access to resources primarily exists in the mesosystem, as
this layer includes the interpersonal connections that allow for the interaction with the systems in
the exosystem such as healthcare and psychiatric care. Transportation, housing, insurance, and
money all facilitate whether the resources in society can be accessed, and whether Black
individuals with schizophrenia can obtain the care and social support they need. The literature
supports this finding, as the systemic structures that cause disparities in housing and financial
status led to poor mental health outcomes (Mensah et al., 2021). Cooper et al. (2002) described
how these barriers blocked an individual’s access to healthcare. Additionally, not being able to
access mental health treatments means the individuals are not receiving any treatment. For
example, the Substance Abuse and Mental Health Services Administration (2020) report noted
that in 2019, 42% of Black adults with a serious mental illness did not receive any treatment. The
ability to access the systems in the exosystem or not is a major factor in the unequal experiences
for the individual.
The recruitment of clinical trial participants occurs at the microsystem, and this is where
the individual’s location and current disease status are situated. The clinical trial staff customize
recruitment activities to schizophrenia, which is a common approach across clinical trial
indications (Kurt et al., 2018). Additionally. the individuals who are available to participate are
the ones who are seeking clinical trials as a potential care option because they do not have access
to other adequate psychiatric care. This concept is supported in the literature as Hampton et al.
(2009) found that the individuals who were in need of healthcare were more motivated to
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participate in research as a way to obtain care. Also, the location of where an individual lives in
relation to the trial site is an important factor in whether they can participate. The recruitment in
clinical trials with a convenience sample was noted by Catlin and Van Hecke (2021), as clinical
trial sites enroll the participants to whom they have access. Part of being able to participate in a
clinical trial involves being able to physically attend the trial visits, and convenience of the
participants in an important factor. Lastly, the microsystem also includes the family, psychiatrists
and other health care providers, and social workers. These are the immediate connections to the
individual that directly interact with and support the individual and are important for the long-
term positive outcomes. The individual’s mental healthcare pro vider has been noted in the
literature to be an important influence in clinical trial decision making process, so the
relationship impacts the treatment options available (Jørgensen et al., 2014). Gaps in the
microsystem for Black individuals with schizophrenia may be filled through other means, such
as participation in clinical trials.
Recommendations for Practice
The findings of this study have led to three recommendations for practice: do not limit
Black patients’ access to schizophrenia clinical trials, increase the number and funding of
CMHCs, and expand locations and increase community engagement to recruit more non-Black
individuals to schizophrenia clinical trials. The first recommendation is for immediate action.
The second recommendation is very large and would require initiatives at the national level for
both policy changes and funding increases. This recommendation would take a long time to
implement, though it is critical. The third recommendation should not be acted upon until the
second recommendation has been implemented, though the study’s findings provided learnings
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that were important to share at this time. This section will describe each recommendation and
will connect it both to the literature and the conceptual framework.
R 1: D L B k P ’ A S z p T
Due to systemic racism, Black individuals have limited access to health care (Jones,
2002) and less access to mental healthcare (Kalin, 2021). The study’s findings have shown that
schizophrenia clinical trials offer a mental healthcare option for patients who otherwise struggle
to obtain consistent and adequate psychiatric care. Additionally, participating in these clinical
trials provides some general healthcare screenings and monitoring, which these individuals often
lack. By limiting the access to clinical trials, it would remove another care option from a group
of patients who already have limited options. Therefore, the first recommendation is not to limit
Black patients’ access to schizophrenia clinical trials.
This recommendation may change in the future if there is a change in the availability of
psychiatric care to make it more equitable for all. However, until that happens, clinical trials fill
several gaps in the individuals’ ecosystem, including the direct care provider (microsystem),
ability to access care (mesosystem), and offer an additional option to biased healthcare systems
(exosystem). Though the clinical trials ecosystem, including the research staff and the research
itself, exists within the system that is biased and cannot separate itself from systemic racism, it is
an important option to help fill the gap in healthcare and mental healthcare.
This first recommendation was not expected at the start of the study. Due to the
importance of racially representative clinical trials, and the concerns stemming from historical
abuses of patients from minority groups in the name of medical research, I had expected to
provide recommendations solely on how to limit participation by Black individuals in these
trials. However, the findings from the study highlighted the need that clinical trial participation
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fills for some individuals with schizophrenia, and this should not be changed unless an
alternative care solution is available.
Recommendation 2: Increase the Number and Funding of CMHCs
The second recommendation is to increase the number and funding of CMHCs to
increase the access to equitable psychiatric healthcare and services for all schizophrenia patients.
This is a very large undertaking that would substantially change the delivery of psychiatric care.
CMHCs are already in existence throughout the country, providing psychiatric care and social
services, though funding and staffing prevent them from providing care and services as
consistently as they could (Mongelli et al., 2020). By increasing the number of CMHCs as well
as increasing their funding, more patients could reliably access psychiatric care and social
services.
Additionally, some CMHCs already provide general medical care, and increased funding
could allow individuals with schizophrenia more access to healthcare. In a survey of 602 full-
service community mental health centers nationwide, Druss et al. (2008) found that 94%
believed that supporting their patients’ general medical health was a priority, though only 51%
had the capacity to do so. Some of the challenges to providing medial care in the system that
already treats these patients includes low reimbursement, challenges with staffing, and space
limitations. There is an opportunity to maximize the treatment offered by CMHCs in order
address both the lack of access to healthcare and mental healthcare. Other studies have also
advocated for utilizing CMHCs to provide general medical care to the patients they treat as those
individuals otherwise have less access to quality healthcare (Krupski et al., 2016; Levinson
Miller et al., 2003).
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From the perspective of the conceptual framework, this recommendation addresses gaps
across the ecological layers. It would create changes in the healthcare and mental healthcare
systems, which is the exosystem, in addition to increasing the ability for individuals to access
these resources to obtain the care they need (mesosystem). Lastly, this recommendation would
fill some of the gaps in the individual’s microsystem by building out their immediate care team
and social support that currently may be lacking.
This recommendation would likely require policy changes with substantial funding in
addition to increasing the number of trained mental healthcare providers such as psychiatrists,
psychologists, and social workers. Gaining alignment at the national level to make these changes
will be a hurdle. However, this recommendation will likely have the biggest impact, as the
study’s findings have shown that the lack of access to psychiatric and general healthcare are the
major problems that need to be addressed. If more patients reliably had access to psychiatric and
general medical care, then clinical trials will no longer need to fill the gap of lack of access to
care, and Black patients will no longer be the convenient population from which to recruit.
Recommendation 3: Expand Locations and Increase Community Engagement to Recruit
More Non-Black Individuals to Schizophrenia Clinical Trials
The third recommendation is to expand the locations of where clinical trials are
conducted and to increase engagement in communities of non-Black individuals to recruit more
racially representative schizophrenia trials. However, it is not recommended to implement these
actions until more Black patients have access to adequate healthcare and psychiatric care.
Radical changes will be needed, as described in the second recommendation, to ensure more
equity in access to care and social services before clinical trial sponsors and sites should focus on
recruiting racially representative clinical trials. Once more Black patients with schizophrenia
117
have access to adequate healthcare and psychiatric care, they will become less convenient of a
sample to recruit from for clinical trials. By default, this will shift the racial representation in
trials.
At this point, the clinical trial sites will need to adjust their recruitment practices to find
participants for the trials. The findings from this study show that location is currently a barrier to
increasing the recruitment of White schizophrenia patients, and clinical trial site should consider
opening satellite sites in communities where non-Black patients live. The use of satellite sites as
a means of making clinical trials more accessible was used for oncology trials during the recent
pandemic (Tan et al., 2020) and could serve as model for other indications as well. Additionally,
based on the successful recruitment practices that were described in this study’s findings, the
clinical trial sites should continue many aspects of patient recruitment through networking,
though directly within non-Black communities. The community outreach activities that were
described the study participants, such as building relationships and establishing trust within the
community, can be utilized within any community and has been shown to increase patient
recruitment (Johnson et al., 2015). Another successful strategy that was described in this study’s
finding was patient-focused recruitment, that includes education about clinical trials and details
about the expectations. These strategies have been recommended as potential solutions to
increase clinical trial participation by Clark et al. (2019).
This third and final recommendation exists within the microsystem, as this is where the
clinical trial recruitment occurs. The location and similarly customized recruitment approaches
are the specific findings that support this recommendation. However, it is critical that these
strategies are not fully pursued until Black individuals have greater access to healthcare and
psychiatric care, in order not to take away an available care option from them.
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Limitations and Delimitations
There were several limitations of this study. The participants self-selected by responding
to a recruitment email, social media post, or through recommendations from colleagues. This
limited the participants to those individuals who had a particular interest in the topic or had other
motivations to participate such as wanting to please the colleague who referred them. Also, three
of the participants were from the same clinical trial site in Chicago. Though each contributed
their unique perspective, the experiences of that site and the location was consistent for all three.
Additionally, the sites represented by the participants were heavily skewed to either
independently owned sites or large site networks. Other types of sites also conduct schizophrenia
clinical trials, most notably academic institutions, and though one additional participant was
from a CMHC, the perspective of other site types was not obtained. A larger and more diverse
sample, with representation from across more regions in the U.S. and more variety in the type of
sites, would have allowed for more confidence in extrapolating the findings across psychiatric
clinical trials. Though consistent with how qualitative studies are described in Merriam and
Tisdell (2016), that qualitative research seeks to understand the perspectives of the small sample
being studied, this study’s limitations of the sample reduce the generalizability of the findings.
Additionally, the participants’ responses were limited depending on the amount and type
of experience they have with recruiting clinical trial participants. At least one participant had less
experience in the clinical trials than expected, and another two participants had many years of
experience, though almost exclusively with schizophrenia trials, which may have made it harder
for them to see the differences in this indication. It was assumed that the interviewees were
truthful in their responses, but the participants’ level of comfort in discussing the topic may have
altered their responses, including some participants providing very brief answers.
119
For the artifact analysis, it was not possible to analyze documents from past clinical trials
as no repository exists with these items, so only materials related to currently enrolling trials
could be found. This limits the data collection to the studies that were recruiting at the time of
data collection. Additionally, as social media advertising occurs only to individuals who are a
within a certain radius of a clinical trial site, the ability to obtain multiple social media examples
was limited based on my physical location.
The delimitations of the study included narrowing the participants to the study
coordinators and recruitment specialists rather than other stakeholders such as principal
investigators or referring psychiatrists. These other stakeholders may have had different insights
on the reasons for the overrepresentation of Black patients in schizophrenia clinical trials.
Additionally, as the interview participants were recruited through social media posts and
snowball referral, this was a network sample that may not have been broadly representative of
the population (Merriam & Tisdell, 2016). Lastly, though the individual with schizophrenia is at
the center of the conceptual framework, both in the ecological systems model and critical race
theory, it was not feasible to have them as participants in this small study.
Recommendations for Future Research
Additional research should be conducted to explore several items that were not addressed
in the current study. One recommendation is to conduct similar studies with different
participants. Exploring the perceptions of research staff from academic institutions and other
research facilities is recommended to understand if their experiences are different than what was
described in this study. Another study that includes the principal investigators and study
physicians may provide yet additional insights. Lastly, a study with individuals from other facets
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of the individual’s microsystem, such as the social worker or family members, would be worthy
of exploration.
Another recommended future study would be to explore the perceptions of the
individuals with schizophrenia directly. This would require some changes to the study design,
such as possibly shorter interviews that are conducted in person at a clinical trial site facility.
Understanding the experiences of the individuals who are participating in the clinical trials
would center the research on them. Though their disease may limit details in the memory or how
they view their situation, the patients’ perspectives would be valuable to understand.
Conclusion
This study sought to explain the reasons why schizophrenia clinical trials were
overrepresented by Black patients. The perceptions of clinical trial staff were explored as these
are the individuals responsible for identifying and recruiting clinical trial participants and are
part of the societal system that places Black individuals at significant disadvantages.
Additionally, understanding the recruitment practices and challenges provided additional insights
to help explain why Black individuals are overrepresented.
The findings from this study have shown that schizophrenia clinical trials that are not
racially representative are a symptom of the larger social and systemic issues in the U.S. rather
than being an isolated problem. Systemic racism has created multiple racial disparities that
impact all aspects of an individual’s life and environment, including unequal access to healthcare
and psychiatric care. This inequality leaves some of the most vulnerable individuals, those who
are Black and seriously mentally ill, untreated and with poorer outcomes. These individuals
participate in schizophrenia clinical trials as a means of an alternative care option, albeit short
term.
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This study is important as it is the first known exploration into the reasons for the
overrepresentation of Black patients in schizophrenia clinical trials. Much emphasis on diversity
in clinical trials, especially to increase recruitment of participants from minority populations, has
been placed on clinical trials in recent decades. The effort is important, as medical research in a
homogeneous population does not adequately address the safety and efficacy of a treatment. The
same problem occurs in the opposite way and may potentially be unique to schizophrenia. Not
only are the schizophrenia clinical trials providing data that may not be adequately generalizable
to the entire population with the condition, but also this participation pattern is likely the result of
the gaps in access to adequate healthcare and psychiatric care for Black individuals. Society was
built on the framework of systemic racism, the impacts of which continue to be felt today.
Continuing to uncover and understand the scope of these impacts is important to push for the
systemic changes needed to bring greater equity to society.

122
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Appendix A
Interview Questions
Number Interview question Potential probe
1 Describe to me your research site,
including staff that works there and
the types of trials you conduct.
How many people work at the
site? Who is responsible for
patient recruitment?
Approximately what proportion
of your studies are
schizophrenia?
2 I would like to understand what goes
into the planning for recruiting
patients into a clinical trial. When you
begin work on a new trial, how do
you recruit patients for it?
How do these plans vary based
on the indication? What are the
differences in how
schizophrenia trials are
recruited?
3 Describe what a recruitment strategy
for a schizophrenia study looks like at
your site.
What role does the sponsor
have with creating the
recruitment strategy?
4 Describe some of the recruitment
materials that you use for
schizophrenia trials.
Who creates these materials?
How are they unique for each
study?
5 What has been your most successful
recruitment strategy for schizophrenia
trials?
Describe whether this strategy
also works for other indications.
Describe a trial where this
strategy has not worked. How
have you changed this strategy
over time or from trial to trial?
151
6 I want to shift gears and talk about
how you communicate with potential
subjects about a trial. Walk me
through the process of your initial
contact with a potential subject for a
schizophrenia trial.
What do you say to the patient?
How do you introduce the
study? How do you present the
study as a possible option for
them?
7 What questions do patients ask at that
initial conversation about the
potential trial?
What information do patients
generally want to know before
making the decision to
participate? What details seem
to be more important to patients
in their decision-making
process?
8 I would like to understand more about
the typical patient you approach for a
trial. What sorts of mental healthcare
services does the typical patient you
recruit to a schizophrenia trial have
when you initially approach them to
participate?
Where do they receive their
psychiatric treatment? Do you
feel they receive adequate
psychiatric treatment? Do you
feel they receive adequate
social services?

9 If a patient does not agree to
participate in the trial, what are the
other options for them?
What does your site do to stay
in contact with the patient?
Describe to me how often
patients participate in multiple
trials? Why do you think some
patients participate in multiple
trials over time?

152
10 Who else is consulted by the patient
in their decision to participate in a
trial?
What is the typical patient’s
living situation? What is the
level of family involvement?
What influence does a social
worker or other service provider
offer?
11 How does the typical schizophrenia
clinical trial participant differ from
other patients with schizophrenia who
do not participate?
Describe the treatment options
available to the patients who
choose not to participate.
Describe the level of social or
familial support of the patients
who choose not to participate.
12 What is the typical ethnic and racial
background of the schizophrenia
patients you recruit for a trial?
What race or ethnic group is
more heavily represented in the
schizophrenia trials, if any?
Why do you think there is an
imbalance?
13 What factors make some studies more
challenging to recruit than others?
What is specific about a study
that will make one more
challenging to recruit than
others?
14 You may have heard about efforts to
increase diversity in clinical trials,
especially to increase participation by
ethnic and racial minority patients.
Tell me your thoughts about this
specific to schizophrenia clinical
trials.
How does the racial or ethnic
distribution of the
schizophrenia trial patients
align with the racial and ethnic
distribution of your site staff?
153
15 Is there something else that I should
know that I have not asked about?
What else should I know?

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Creator Skubiak, Taisa Roma (author)

Core Title Exploration of the reasons for the overrepresentation of Black patients in schizophrenia clinical trials

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Degree Conferral Date 2023-08

Publication Date 07/21/2023

Defense Date 07/13/2023

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