More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant

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.

Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates

“…CTTI conducted a qualitative descriptive study using semi-structured interviews with investigators and clinical trial sponsors to 1) describe the characteristics that define the conduct of quality clinical trials and concerns related to the conduct of quality clinical trials; 2) identify critical tasks that lead to the conduct of quality trials; 3) identify key knowledge and skills necessary to perform critical trial tasks with quality; and 4) discover gaps and redundancies in existing clinical trial training, including GCP training on critical tasks. Details of participant eligibility and selection, data collection and analysis, as well as the results of this study, focusing on critical tasks and burdens, redundancies, and gaps in GCP training are described in Swezey et al [9].…”

“…Using evidence gathered through qualitative interviews with subject matter experts [9] and a multi-stakeholder expert meeting [10], CTTI developed consensus-based recommendations on how to identify qualified site teams while simultaneously reducing inefficiencies in training and better preparing site teams for the conduct of quality clinical trials. These recommendations address how to implement a more efficient and effective means of qualification of investigators and delegates, determine whether a site team is a good fit for a particular protocol, and improve the quality of clinical trial conduct.…”