More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant
| Autor: | Natasha Phrsai, F. Hunter McGuire, Tina Chuck, Janette Panhuis, Patricia Hurley, Kathy Goldstein, Carrie B. Dombeck, Brian Perry, Christina Brennan, Teresa Swezey, Amy Corneli |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
media_common.quotation_subject
education Occupational safety and health Article Clinical investigator Investigator training 03 medical and health sciences general_medical_research 0302 clinical medicine Clinical trials Informed consent Quality (business) Relevance (information retrieval) 030212 general & internal medicine media_common Pharmacology Medical education lcsh:R5-920 General Medicine Quality Clinical trial Good clinical practice Thematic analysis Psychology lcsh:Medicine (General) 030217 neurology & neurosurgery |
| Zdroj: | Contemporary Clinical Trials Communications, Vol 19, Iss, Pp 100606-(2020) Contemporary Clinical Trials Communications |
| ISSN: | 2451-8654 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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