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CLINICAL TRIALS DRIVEN BY INVESTIGATOR-SPONSORS: GCP COMPLIANCE WITH OR WITHOUT PREVIOUS INDUSTRY SPONSORSHIP
By
Ellen R. Whalen
A Dissertation Presented to the
FACULTY OF THE USC SCHOOL OF PHARMACY
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF REGULATORY SCIENCE
May 2013
Copyright 2013 Ellen R. Whalen
Object Description
| Title | Clinical trials driven by investigator-sponsors: GCP compliance with or without previous industry sponsorship |
| Author | Whalen, Ellen R. |
| Author email | ellen.whalen@med.usc.edu;ewhalen@alumni.usc.edu |
| Degree | Doctor of Regulatory Science |
| Document type | Dissertation |
| Degree program | Regulatory Science |
| School | School of Pharmacy |
| Date defended/completed | 2013-01-23 |
| Date submitted | 2013-02-06 |
| Date approved | 2013-02-07 |
| Restricted until | 2013-02-07 |
| Date published | 2013-02-07 |
| Advisor (committee chair) | Richmond, Frances J. |
| Advisor (committee member) |
Baron, Melvin F. Pacifici, Eunjoo Welsh, Mickie |
| Abstract | The present study was conducted to evaluate using the Plan-Do-Check-Act cycle (PDCA) typical of quality control systems to evaluate the state of compliance with Good Clinical Practices in clinical trials directed by investigators who also had the role of sponsor, either with or without recent experience in trials sponsored by industry. A targeted audit tool was constructed with reference to the most common deficiencies found in FDA and OHRP warning letters to principal investigators. The tool was validated by a focus group of individuals with an established record of engagement in the conduct or oversight of clinical trials. A sample of clinical trials conducted by both industry experienced and inexperienced principal investigators was audited using the tool at a single research university. Industry inexperienced investigators in this sample were at least as compliant, and sometimes more compliant, with GCPs than industry experienced investigators. Areas of challenge for both groups included documentation systems, staffing and end-of-trial care transitions. Using the PDCA cycle, deficiencies were often recognized at the planning stage, and additional challenges associated with monitoring were common at the checking phase. These results may help educators and risk experts in universities to target initiatives that focus on areas of greatest need and to maximize the impact of training resources that improve the safety of participants in clinical trials. |
| Keyword | clinical research quality control; clinical trials; GCP compliance; good clinical practices; PDCA cycle; sponsor-investigators |
| Language | English |
| Part of collection | University of Southern California dissertations and theses |
| Publisher (of the original version) | University of Southern California |
| Place of publication (of the original version) | Los Angeles, California |
| Publisher (of the digital version) | University of Southern California. Libraries |
| Provenance | Electronically uploaded by the author |
| Type | texts |
| Legacy record ID | usctheses-m |
| Contributing entity | University of Southern California |
| Rights | Whalen, Ellen R. |
| Physical access | The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the author, as the original true and official version of the work, but does not grant the reader permission to use the work if the desired use is covered by copyright. It is the author, as rights holder, who must provide use permission if such use is covered by copyright. The original signature page accompanying the original submission of the work to the USC Libraries is retained by the USC Libraries and a copy of it may be obtained by authorized requesters contacting the repository e-mail address given. |
| Repository name | University of Southern California Digital Library |
| Repository address | USC Digital Library, University of Southern California, University Park Campus MC 7002, 106 University Village, Los Angeles, California 90089-7002, USA |
| Repository email | cisadmin@dots.usc.edu |
| Archival file | uscthesesreloadpub_Volume7/etd-WhalenElle-1429.pdf |
Description
| Title | Page 1 |
| Contributing entity | University of Southern California |
| Repository email | cisadmin@dots.usc.edu |
| Full text | CLINICAL TRIALS DRIVEN BY INVESTIGATOR-SPONSORS: GCP COMPLIANCE WITH OR WITHOUT PREVIOUS INDUSTRY SPONSORSHIP By Ellen R. Whalen A Dissertation Presented to the FACULTY OF THE USC SCHOOL OF PHARMACY UNIVERSITY OF SOUTHERN CALIFORNIA In Partial Fulfillment of the Requirements for the Degree DOCTOR OF REGULATORY SCIENCE May 2013 Copyright 2013 Ellen R. Whalen |
