A new paper published by Clinical Trials Transformation Initiative (CTTI) in the DIA Therapeutic Innovation & Regulatory Science journal identifies key elements and strategies for increasing Good Clinical Practice (GCP) training efficiency (see Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency).
We spoke to one of the paper’s authors, Dr. Jonathan Seltzer, MD, MBA, President, ACI Clinical, about CTTI’s recommendations.
Q: CTTI’s recommendations state that advanced and role-based GCP training should be considered for those who have already completed initial GCP training. What value do you see in providing advanced-level GCP training, rather than repeat initial GCP training, to investigators and the clinical research industry at large?
Dr. Seltzer: Advanced or real-world training that integrates adult learning methods, such as interactive feedback, case studies, and group exercises, may provide a higher degree of knowledge retention. However, this format may be challenging to administer to large, diverse audience, since many of these trainings may require in-person training.
Also, consideration should be given to whether training by active involvement or serving as a Principal Investigator (PI) in new studies could be an indicator of GCP competence, and thus should qualify as acceptable training. Another approach is to foster mentoring programs where new investigators are paired with more experienced mentors who provide guidance on interpreting and building upon the fundamentals of GCP.
Q: Same question for investigator-specific training?
Dr. Seltzer: Some of the 13 key elements of GCP training may require deeper focus depending on the individual’s role. For example, the element “Investigator’s Qualifications and Agreements” specifies that the investigator should be able to identify what it means to be a qualified investigator with a qualified team, know how to supervise and delegate tasks, and know what is required in Form FDA 1572 (“Statement of the Investigator”). However, a GCP course for a study coordinator at a site may focus on other elements related to site support duties such as data management and trial records.
Q: While not making a specific recommendation in support of online GCP training, CTTI does state that an online format “may be the most practical to impart GCP training.” What challenges do investigators face that would make online GCP training a more practical option?
Dr. Seltzer: Time and resource constraints are challenging within all professions, and clinical research is certainly no different. Since clinical trial participant visits often occur during workday hours, and online learning can essentially occur at any hour of any day, the flexibility provided by online learning could be more practical than other options. However, while online training is attractive because of flexibility of access, CTTI heard concerns from some individuals that online learning may not be retained as well as in-person approaches. CTTI prefers to allow flexibility to the administering institutions to fulfill their specific needs.