Version 1
: Received: 17 January 2020 / Approved: 19 January 2020 / Online: 19 January 2020 (04:46:48 CET)
How to cite:
Swezey, T.; McGuire, F.H.; Hurley, P.; Panhuis, J.; Goldstein, K.; Chuck, T.; Dombeck, C.; Perry, B.; Brennan, C.; Phrsai, N.; Corneli, A. More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant. Preprints2020, 2020010209. https://doi.org/10.20944/preprints202001.0209.v1
Swezey, T.; McGuire, F.H.; Hurley, P.; Panhuis, J.; Goldstein, K.; Chuck, T.; Dombeck, C.; Perry, B.; Brennan, C.; Phrsai, N.; Corneli, A. More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant. Preprints 2020, 2020010209. https://doi.org/10.20944/preprints202001.0209.v1
Swezey, T.; McGuire, F.H.; Hurley, P.; Panhuis, J.; Goldstein, K.; Chuck, T.; Dombeck, C.; Perry, B.; Brennan, C.; Phrsai, N.; Corneli, A. More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant. Preprints2020, 2020010209. https://doi.org/10.20944/preprints202001.0209.v1
APA Style
Swezey, T., McGuire, F.H., Hurley, P., Panhuis, J., Goldstein, K., Chuck, T., Dombeck, C., Perry, B., Brennan, C., Phrsai, N., & Corneli, A. (2020). More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant. Preprints. https://doi.org/10.20944/preprints202001.0209.v1
Chicago/Turabian Style
Swezey, T., Natasha Phrsai and Amy Corneli. 2020 "More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant" Preprints. https://doi.org/10.20944/preprints202001.0209.v1
Abstract
Background: Good clinical practice (GCP) training is the industry standard for ensuring the quality conduct of registrational clinical trials. However, concerns have been raised about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure the quality conduct of clinical trials. We used applied thematic analysis to analyze the data. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks; however, they described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the relevance of GCP training to investigators and their delegates. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses critical tasks necessary to the quality conduct of clinical trials, they articulated the need for significant improvement in the design, content, and presentation of GCP training.
Keywords
good clinical practice; clinical trials; quality; investigator training; clinical investigator
Subject
Medicine and Pharmacology, Clinical Medicine
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received:
10 February 2020
Commenter:
Erin Schellhorn
The commenter has declared there is no conflict of interests.
Comment:
Great article. This is precisely the reason we created our own training course 17 years ago under the leadership of Dr. Michael Koren. It is a unique CME course, taught primarily by physicians for physicians, differs from other types of investigator training that focus solely on regulatory knowledge. Our program covers a review of all the skill sets physicians and other clinical research professionals need to master success in clinical research. Using case-based scenarios that are pulled directly from our own experiences over the past 20 years of doing research. It is engaging and informative, what many other programs lack. The readership would benefit from a follow up article with program suggestions or solutions to this knowledge gap.
Commenter: Erin Schellhorn
The commenter has declared there is no conflict of interests.