Although good clinical practice (GCP) training has long been considered the industry standard for ensuring investigators are qualified for the high-quality conduct of clinical trials, little evidence has been collected to determine whether it actually provides the knowledge and skills to equip investigators and their delegates to conduct clinical trials.
To address this issue, CTTI convened an expert meeting in December 2017 to discuss action that can be taken to inform the efficient and effective qualification of site investigators and their delegates. The meeting (see one-page summary) included representatives from pharmaceutical companies, government, research sites, contract research organizations, patient representatives, and other groups.
Meeting participants collaborated to refine a draft framework defining characteristics synonymous with the quality conduct of clinical trials. They discussed the need to shift the focus from individual investigators to the entire study team and identified value in mentorship, just-in-time training, and peer-to-peer networks to support site personnel in their specific roles. In addition, participants probed how it may be possible to develop and deliver more patient-centric training, foster a culture of learning, and drive the evolution of investigator qualification to include more adult learning approaches and a focus on how to apply knowledge—not just recall it. Attendees also identified the need for a harmonized system to better help sponsors identify suitable sites without mandating specific training.
As a next step in its Investigator Qualification work, CTTI will develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates.