More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant

作者：Teresa Swezey, F. Hunter McGuire, Patricia A. Hurley, Janette Panhuis, Kathy Goldstein, Tina Chuck, Carrie Dombeck, Brian Perry, Christina Brennan, Natasha Phrsai, Amy Corneli · 发表于：Contemporary Clinical Trials Communications · 年份：2020 · DOI：10.1016/j.conctc.2020.100606 · 被引用次数：15 · 研究领域：Ethics in Clinical Research、Pharmaceutical industry and healthcare、Animal testing and alternatives

BACKGROUND: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist 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 quality conduct of clinical trials. Data were examined using applied thematic analysis. 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 but also 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 incr...