Evidence suggests that many investigators are leaving clinical research due to burdens imposed by trial-related responsibilities—a trend that could hinder the quality and efficiency of clinical trials. CTTI is addressing these and other issues in a rollout of evidence-based investigator community recommendations.

At the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Sat., Oct. 7, CTTI will present its new set of recommendations designed to support and strengthen the site investigator community through activities aimed at:

• Developing site-based research infrastructure and staff
• Optimizing trial execution and conduct
• Improving site budget and contract negotiations
• Identifying additional trial opportunities for interested investigators

These recommendations, which lay out practical strategies that can help all stakeholders contribute to building a more supportive and sustainable clinical trials enterprise, were developed through CTTI’s Investigator Community Project.

Panel Discussion: Four Ways to Grow & Maintain a Strong Investigator Community
Date & Time: Sat., Oct. 7, 4:30-5:30 PM EDT (8:30-9:30 PM GMT)
Presenters:

• Robin Douglas, Site Solutions Director, Site and Patient Networks, QuintilesIMS
• Doug Peddicord, Executive Director, Association of Clinical Research Organizations
• Gerrit Hamre, Project Leader, Clinical Trials Transformation Initiative

Gain new insights into challenges affecting investigator retention and potential solutions

Evidence shows that the pool of qualified clinical investigators in the United States is shrinking, while at the same time a high percentage of investigators are likely to stop leading trials after conducting just a single drug study—trends that threaten the quality and efficiency of U.S. regulatory trials.

On April 5, 2017, CTTI convened an expert meeting to explore this issue and others related to clinical trial investigator turnover and retention. A comprehensive meeting summary presents survey and interview data gathered from current and former trial investigators and explores approaches that can help investigators overcome the practical challenges of conducting clinical trials.

CTTI’s Investigator Community Project was created to better understand why some clinical investigators remain actively engaged in clinical research but others decide to leave it after a single experience. CTTI is applying these insights to develop strategies that can improve investigator retention and reduce turnover, ultimately leading to more efficient, higher-quality clinical trials. The multi-stakeholder project team will continue to review evidence and incorporate consensus findings from the expert meeting as it develops recommendations and other products that can be used to strengthen the investigator community.

Learn About Issues Affecting the Supply of Experienced and Engaged Trial Investigators

Clinical trials work best when experienced investigators conduct research activities. But chronically high rates of investigator turnover mean that a substantial proportion of FDA-regulated drug trials are led by clinicians who step forward to conduct a trial, but then do not go on to conduct other trials—so-called “one and done” investigators. This has serious implications, because investigator turnover is associated with higher costs and greater levels of inefficiency for clinical trials.

To get a clearer picture of what factors are driving this turnover and how it affects the investigator community, CTTI researchers surveyed clinicians about factors affecting their decisions to conduct only one FDA-regulated drug trial. Using the federal Bioresearch Monitoring Information System (BMIS), which contains data on physicians who have submitted forms required for participation in FDA-regulated trials (the “Form FDA 1572”), they identified investigators who had conducted only one FDA-regulated trial (including trials that were still ongoing) at the time of the survey. They were particularly interested in learning what kinds of barriers to continued participation these investigators were encountering and which ones had the most impact on their decision to conduct only one FDA-regulated drug trial.

The CTTI group’s findings, which have been published in the journal Contemporary Clinical Trials Communications, show that a little over half of the roughly 200 investigators who participated in the survey did not plan to take part in any further FDA-regulated drug trials. Among this group, the reasons given for not wishing to participate further in such trials differed substantially according to whether the survey participants were academic or non-academic/community-based clinicians. More “one and done” academic investigators indicated they were no longer participating because of a lack of available trials, while “one and done” community investigators were more likely to cite personal choice as the reason for not participating.

Although the investigators surveyed acknowledged a wide variety of barriers to participating in FDA-regulated drug trials, several broad categories were identified across most investigators:

• Time requirements and difficulty in balancing workloads
• Burdens imposed by data and safety reporting
• Problems with different aspects of trial finances

The survey results revealed high rates of investigator turnover for FDA-regulated drug trials among the study participants; they also provide details and insights into the reasons that site investigators stop conducting such studies. This study was done as part of a larger CTTI project that focuses on strengthening the community of clinical investigators. Work is now underway on extending the findings from this preliminary survey to create a better understanding of the factors that influence clinicians’ decisions to participate as investigators in multiple FDA-regulated drug trials.

Learn more about CTTI’s Strengthening the Investigator Site Community Project.