One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

Abstract

Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA) Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs) decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1) workload balance (balancing trial implementation with other work obligations and opportunities) (63.8%); 2) time requirements (time to initiate and implement trial; investigator and staff time) (63.4%); and 3) data and safety reporting (56.5%). Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

Drivers of Start-Up Delays in Global Randomized Clinical Trials

“…However, after participating in a clinical study, many sites do no elect to participate in a subsequent one. Key challenges faced by investigators include workload balance, time and financial requirements, complex regulations and contracts, lack of infrastructure, inadequate training, and data collection challenges [ 37 ].…”

Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database

“…Many documented barriers have been associated with a reluctance to continue in research [ 11 , 12 , 15 , 26 ], and our recent related study underscores this point among a cohort definitively identified as comprising “one-and-done” investigators [ 18 ]. One particularly salient finding from this investigation was that among this group of researchers, nearly half (45%) expressed an interest in continuing to participate in clinical trials, but indicated that they lacked opportunities to do so [ 18 ]. Building on these findings by combining insights into reasons for stopping participation with the ability to clearly identify “stayers” who remain continuously involved in research could provide valuable insights and strategies into overcoming barriers affecting investigator participation.…”

Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative

“…One recent examination of data contained in the US FDA's Bioresearch Monitoring Information System (BMIS) database found that from 1999 to 2015, the number of clinical trial investigators submitting a Form FDA 1572 declined by approximately one-third [2]. Furthermore, evidence suggests that many investigators are leaving clinical research due to difficulty balancing workload, time requirements, data and safety reporting burdens, and financial issues [3].…”

“…To date, little is known about why investigators stop conducting site-based research or strategies necessary to overcome challenges frequently encountered by investigators. Our previous research found that nearly half (44%) of investigators expressed an interest in continuing to participate in clinical trials, but indicated that they lacked opportunities to do so [3]. This trend of investigator turnover and researchers being inadvertently driven away from clinical research has the potential to threaten the overall quality and efficiency of clinical trials.…”

“…To explore the reasons for this high rate of turnover, the Clinical Trials Transformation Initiative (CTTI)—a public-private partnership to develop and drive adoption of practices to increase the quality and efficiency of clinical trials—developed the Strengthening the Investigator Site Community Project. The Investigator Community Project team gathered data through a review of the BMIS database [2], a survey of investigators who completed only one clinical trial (“one and done” site investigators) [3], qualitative interviews with experienced investigators who have completed multiple prior clinical trials, and a multi-stakeholder meeting convened by CTTI.…”