CTTI has released a new preprint paper describing its recommended approach for identifying and preparing investigators and their delegates to perform clinical research. The paper suggests that by moving beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution, sponsors, CROs, investigators, and other research professionals may be able to more efficiently find and train investigators for quality research.
Specifically, CTTI recommends complementing previous GCP training with a fit-for-purpose, risk-based training approach to close identified gaps in knowledge or skills. This multifaceted approach to training can enrich understanding of how GCP principles apply to the conduct of a particular clinical trial and help investigators grasp how to better apply quality principles in a specific setting. Combining the real-world application of GCP principles with role- and protocol-specific instruction has the potential to add greater value to the investigator qualification process, leading to the higher quality conduct of trials.
CTTI used findings from qualitative research with investigators and clinical trial sponsors, along with input from an expert meeting with multiple stakeholders, to develop the recommendations. The research identified gaps and redundancies in the current training of investigators and their delegates, as well as a common theme: the didactic, one-size-fits-all approach most commonly used for training investigators and documenting their qualification often introduces redundancies and minimizes the value of previous training.
In the paper, CTTI offers detailed recommendations for how sponsors, CROs, and site teams can respond to these insights and positively shift the investigator training culture, as well as further discussion of how a targeted learning approach can better prepare investigators and their delegates to conduct quality clinical trials.