Trends in Clinical Trial Investigator Workforce and Turnover: An Analysis of the U.S. FDA 1572 BMIS Database

Clinical Trial Investigator Workforce

TrialSite News reviews and summarizes an important study showcasing the high turnover rates among clinical trial investigators.Investigators may contribute to inefficiency, instability, and increased cost for clinical research; however, factors contributing to investigator turnover have not been well characterized.

Deep Expertise Among Authors

Industry-established authors from Duke Clinical Research Institute, University of British Columbia, Society for Clinical Research Sites, Academy of Medical-Surgical Nurses and the industry-backed Clinical Trials Transformative Initiative (CTTI) come together to summarize some profound challenges and constraints in the clinical trials business, detailed below.

Most Clinical Investigators Still “One and Done”

FDA Bioresearch Monitoring Information System (BMIS) identified 172,453 unique investigators who submitted a Form FDA 1572 during the study interval (1999-2015). The authors report that of this total, 85,455 were classified as having done only a single study (“one and done” investigators); 21,768 as being intermittently involved in research activity (“stop and go” investigators); and 65,231 as investigators who were continuously involved in clinical research (“stayer” investigators).

Total University of Clinical Investigators Declining

From 1999 to 2015, investigators submitting a Form FDA 1572 to the BMIS database declined by approximately 33% and the proportion of investigators involved in only one trial increased, signaling potential adverse trends in the clinical investigator workforce.

What Underlies the Trends

The “one and done” problem is well-known, and the general trend that the number of actual investigators submitting forms to participate in clinical research has substantially declined.  Moreover, there are profound shifts in health care systems in the United States, such as intensifying infusion of private equity into commercial research sites, implicating more sharp negotiation practices with global industry sponsors.

Follow the link to the source to read the entire report.

*A special mention to Christine Pierre who passed away last year. Ms. Pierre launched the Society for Clinical Research Sites (SCRS) and was a exceptionally giving human being who impacted clinical research with her commitment and passion for research sites.

Lead Research/Authors

Christine Pierre*

Christopher B. Fordyce 

Matthew T Roe 

Terri Hinkley 

Gerrit Hamre 

Pamela Tenaerts  

Jonathan McCall

James D. Topping