Recent evidence suggests that many investigators choose not to continue leading clinical trials after an initial experience in another trial—and an enormous amount of time and resources are expended by clinical trial investigators, sponsors, and other stakeholders to initiate new investigators into clinical trial processes. Additionally, analyses of Form FDA 1572s (“Statement of Investigator”) indicate a high rate of turnover among investigators conducting FDA-regulated drug trials and dwindling numbers of active investigators. Approximately 40% of unique investigators annually choose not to participate in another FDA-regulated trial, based on review of the publicly available BMIS data. These high rates of attrition among U.S. investigators and the resulting need to train and initiate new investigators to maintain an adequate pool of qualified trial leaders places a strain on  site resources and can have a negative effect on overall trial performance.

Investigator Community: Strengthening the Investigator Site Community (2014-2017)

• Obtain a more thorough understanding of factors that influence investigators’ decisions to leave or remain in clinical research practice
• Facilitate an informed discussion of the challenges to and strategies for ensuring an adequate investigator workforce
• Provide practical, action-based recommendations that can facilitate the engagement, training, and retention of qualified site investigators and support personnel

This effort aimed to:

• Guide sites, sponsors, clinical research organization, and medical centers in developing sustainable supportive infrastructure, training, and mentoring for site-based investigators
• Reduce attrition and turnover among site investigators
• Increase long-term engagement and participation in clinical research leadership activities
• Foster greater efficiency and higher quality in clinical trial start-up and study conduct
• Provide a more detailed, granular look at factors affecting investigator participation in clinical trials and enable a better understanding of longer-term patterns and trends affecting the overall pool of qualified site investigators

• Analysis of Form FDA1572 data, including data contained in the FDA BMIS database
• Interviews with investigators
• Survey of site investigators who left the clinical trial enterprise
• Survey of site investigators who remain engaged in the clinical trial enterprise
• Consensus of input from stakeholders at expert meeting

Results from a CTTI survey of “one-and-done” investigators who ended their involvement as a site principal investigator in research after a single clinical trial revealed four main reasons: 1) excessive time commitments required, 2) burden of data and safety reporting, 3) trial responsibilities taking away from other activities, and 4) dissatisfaction with study finances. Site investigator interviews were also conducted to identify other reasons why investigators have chosen to continue conducting FDA-regulated drug trials.

These results were presented and discussed at a multi-stakeholder expert meeting held on Apr. 5, 2017, and published as a peer-reviewed research article. The consensus findings from this meeting were used to develop a set of recommendations aimed at reducing attrition rates for U.S. clinical trial investigators and strengthening the field of qualified and productive investigators.

An additional investigation is underway, examining information contained in the FDA’s BMIS database, which houses electronic data from all Form FDA 1572s submitted by investigators prior to participating in FDA-regulated drug trials. These analyses are focused on characterizing temporal trends in investigator participation in FDA-regulated clinical trials, and developing a “phenotype” of characteristics that discriminate “one-and-done” investigators from those who participate intermittently or continuously in clinical research. A manuscript reporting on results from these analyses is being prepared for submission to a peer-reviewed journal.

Results from a CTTI survey of “one-and-done” investigators who ended their involvement as a site principal investigator in research after a single clinical trial revealed four main reasons: excessive time commitments required, burden of data and safety reporting, trial taking away from other activities, and dissatisfaction with finance. Additionally, site investigator interviews were conducted to identify other reasons why investigators have chosen to continue conducting FDA-regulated drug trials. These results were presented and discussed at a multi-stakeholder expert meeting held on April 5, 2017. The consensus findings from this meeting are being used to develop recommendations and other products that can help reduce attrition rates for U.S. clinical trial investigators and strengthen the field of qualified productive investigators.