Investigator Qualification
CTTI Paper Offers Suggested Solutions for Improving Good Clinical Practice Training
A new CTTI paper, detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training, has published in Contemporary Clinical Trials Communications.
The paper, “More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant,” outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical investigators and research sponsors. While interview respondents recognized that GCP training addresses critical tasks necessary for the quality conduct of clinical trials, many found it burdensome and repetitive—one interviewee said the training was seen as “just another box to check off.”
CTTI’s paper also highlights respondents’ suggestions for navigating these challenges, noting a need for significant improvement in the design, content, presentation, and training of GCP guidelines. These findings, together with other evidence, informed CTTI’s Investigator Qualification recommendations for alleviating the burden of training and making it more engaging and applicable to real-world clinical research scenarios.
New Paper Offers Suggested Solutions for Improving Good Clinical Practice Training
CTTI has released a new preprint paper detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training.
The paper, “More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant,” outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical investigators and research sponsors. While interview respondents recognized that GCP training addresses critical tasks necessary for the quality conduct of clinical trials, many found it burdensome and repetitive—one interviewee said the training was seen as “just another box to check off.”
CTTI’s paper also highlights respondents’ suggestions for navigating these challenges, noting a need for significant improvement in the design, content, presentation, and training of GCP guidelines. These findings, together with other evidence, informed CTTI’s Investigator Qualification recommendations for alleviating the burden of training and making it more engaging and applicable to real-world clinical research scenarios.
New Publication Features CTTI Recommendations For Improving Investigator Qualification
A peer-reviewed article highlighting CTTI recommendations for improving investigator qualification was published this month in Contemporary Clinical Trials. This article details how to implement a more efficient and effective way to identify and prepare investigators and their delegates for the conduct of quality clinical trials, and how to determine whether a site team is a good fit for a particular protocol.
The paper urges organizations to move beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution and recommends pairing existing GCP training with a fit-for-purpose, risk-based training approach to address needed knowledge or skills.
CTTI used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions.
New Paper Offers Recommendations for Efficient Identification and Training of Investigators
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.
Webinar Now Available: CTTI’s New Recommendations to Improve Investigator Qualification
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.