Strengthening the Investigator Site Community
Knowledgeable and experienced site investigators are vital to conducting efficient, high-quality clinical trials. However, the burdens of research are contributing to high rates of investigator turnover and driving some researchers away from clinical research altogether—a trend that could threaten the overall quality and efficiency of clinical trials.
Through the Investigator Community project, CTTI investigated factors that influence investigators’ decisions to leave or remain in clinical research practice. Based on surveys, investigator interviews, and an analysis of the FDA Bioresearch Monitoring Information System (BMIS) database, our team developed practical recommendations that address the issues associated with investigator turnover.
CROs, sponsors, health systems, investigators, and others can use these recommendations to create a research environment that sustains long-term engagement, and fosters improved quality and efficiency in clinical trials.
Sheryl Jacobs, Vice President of Global Development Operations at Amgen
“These recommendations are a blueprint for creating a system that supports successful and sustainable clinical trials. The Investigator Community Project provides straightforward, actionable steps that the biopharmaceutical industry can take to ensure that clinical research remains an attractive arena for skilled and talented people looking to make a difference in patients’ lives.”
Christine Pierre, Founder of SCRS
“For an investigator to effectively manage their site and study there are many elements that must be given serious consideration—and are often unknown at the onset of the first study—to ensure they do not become a ‘one and done'. These recommendations help guide that direction for the site and the rest of the industry. The true impact will only be realized when all stakeholders embraces these recommendations.”
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)
This effort aimed to:
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.
|Project Manager||Gerrit Hamre*||Clinical Trials Transformation Initiative|
|Social Science Lead||Amy Corneli||Clinical Trials Transformation Initiative|
|Team Leader||Terry Hinkley||Association of Clinical Research Professionals|
|Team Leader||Christine Pierre||Society for Clinical Research Sites|
|Team Leader||Matthew Roe||Duke University|
|Team Member||Christopher Fordyce||University of British Columbia|
|Team Member||David Ciavarella||CR Bard, Inc.|
|Team Member||John Isidor||Consortium of Independent Review Boards|
|Team Member||Elizabeth Mahon||Johnson and Johnson Pharmaceutical Research and Development|
|Team Member||Robin Douglas||IQVIA|
|Team Member||Kaitlin Malone||Amgen|