During a public webinar on Thurs., Nov. 15, CTTI released new recommendations that propose a fresh approach for investigator qualification. The webinar, now available online, explored how these new recommendations can move qualification activities beyond repetitive one-size-fits-all training to include individual experience and protocol-specific preparation.

While current FDA regulations state that sponsors and their delegates are responsible for selecting qualified investigators, no guidelines exist for how to meet this requirement. Good Clinical Practice (GCP) training is widely used as the industry standard, but there is little evidence that it sufficiently qualifies investigators and their delegates to conduct quality clinical trials.

 

CTTI convened a team of experts and leaders across the clinical trials enterprise to develop new recommendations and resources that can help to implement a more efficient and effective qualification process. CTTI’s recommended approach recognizes previous training and experience, identifies gaps in knowledge and skills, and improves understanding of how to apply GCP principles to the conduct of clinical trials.

 

“If we are to support successful clinical trial conduct, we can’t look at training in isolation,” said Sabrina Comic-Savic of The Medicines Company, who presented during the webinar. “These recommendations come as part of an overall approach that CTTI is taking to improve the whole ecosystem where sites operate in order to support the quality conduct of clinical trials.”

 

The webinar also featured Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) and Kate Haratonik of Genentech—a member of the Roche Group.

CTTI released new recommendations proposing a new approach for investigator qualification today during a public webinar. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.

 

While Good Clinical Practice (GCP) training is widely used as the industry standard for investigator qualification, there is little evidence that completion of GCP training alone sufficiently qualifies investigators and their delegates to conduct quality clinical trials. In fact, the most common deficiencies noted during investigator inspections are often directly related to GCP principles. Furthermore, redundant GCP training creates an unnecessary burden for site teams and limits the opportunity for more valuable, protocol-specific learning and preparation.

 

To address this challenge, CTTI convened a team of experts and leaders across the clinical trials enterprise to develop new recommendations and resources that can help in implementing a more efficient and effective means of qualification. CTTI’s recommended approach recognizes previous training and experience, identifies gaps in knowledge and skills, and improves understanding of how to apply GCP principles to the conduct of clinical trials.

 

By implementing CTTI’s recommendations, stakeholders could improve the execution of study protocols and ultimately the overall quality of trials. The recommendations can also help stakeholders create a culture of collaboration and provide ongoing support through formalized mentorship and knowledge-sharing platforms.

 

Recognizing that successful clinical trials require not only qualified site teams but also well-designed protocols and robust site-based infrastructure, CTTI encourages site teams to use these new recommendations in conjunction with its Quality by Design recommendations on protocol development and Investigator Community recommendations for a holistic approach to conducting quality clinical trials.

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.