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

Abstract

Background High turnover rates among clinical trial investigators contribute to inefficiency, instability, and increased costs for the clinical research enterprise; however, factors contributing to investigator turnover have not been well characterized. Methods Using information from the U.S. Food and Drug Administration's Bioresearch Monitoring Information System (BMIS), we examined trends in the overall clinical investigator workforce and within specific “phenotypes” as well as differences by investigator location (U.S.-based vs. non-U.S.-based). We identified unique investigators within the database, stratifying them into one of three “phenotypes”: those with one Form FDA1572 submission across the study interval (“one-and-done”); those with two or more submissions but with substantial intervals between trials (“stop-and-go”); and those with two or more submissions and continuous involvement in multiple trials (“stayers”). Results Of the 172,453 unique investigators who submitted a Form FDA 1572 during the study interval (1999–2015), 85,455 were classified as “one-and-done” investigators; 21,768 as “stop-and-go” investigators; and 65,231 as “stayer” investigators. The total number of investigators declined across the study interval. Among all subgroups, only “one-and-done” investigators showed growth across the study period, largely driven by increases in non-U.S.-based investigators. “Stop-and-go” investigators showed declines for both U.S.-based and non-U.S.-based investigators, as did “stayers,” who showed the largest absolute and proportional declines of all subgroups. Conclusions From 1999 to 2015, investigators submitting a Form FDA 1572 to the BMIS database declined by approximately one-third and the proportion of investigators involved in only one trial increased, signaling potential adverse trends in the clinical investigator workforce. Strategies for sustaining investigator engagement warrant further exploration.

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

“…The study also explored differences associated with investigator location (U.S.-based or non-U.S.-based). Full details of the methods and results of this survey have been described previously [2]. Briefly, investigators were stratified into 1 of 3 “phenotypes:” “one and done” – investigators with 1 Form FDA 1572 submission across the study interval; “stop and go” – investigators with at least 2 submissions for whom the interval between first and second submission occurred beyond the 75th percentile; and “stayer” – investigators with at least 2 submissions for whom the interval between first and second submission occurred within the 75th percentile.…”

“…High attrition rates for investigators working on United States (US) Food and Drug Administration (FDA) regulated trials—and the resulting need to continuously recruit and train new investigators—increase the costs of performing clinical trials and threaten the quality and efficiency of trial conduct [1]. Analyses of Form FDA 1572s (“Statement of Investigator”) suggest that turnover among investigators working on FDA-regulated trials is increasing [2]. 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].…”

“…Analyses of Form FDA 1572s (“Statement of Investigator”) suggest that turnover among investigators working on FDA-regulated trials is increasing [2]. 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 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.…”

Assessing clinical investigators’ perceptions of relevance and competency of clinical trials skills: An international AIDS Malignancy Consortium (AMC) study

“…Over the years, there has been an increase in clinical trials conducted worldwide [2]. With the increase in the number of clinical trials that are developed and implemented, there is a commensurate demand for a workforce that can support these studies [3][4][5]. Conducting a clinical trial requires a team who collectively are familiar with regulatory requirements, reporting efficacy and safety measures, ethical considerations, data management, and analysis considerations [6].…”