01 Dec A small number of PIs account for most activity in pharma-sponsored trials in US
By Harold E. Glass, The Association of Clinical Research Professionals (ACRP)
In a recent three-year period, more than 40% of active principal investigators (PIs) in the United States conducted just one industry-sponsored pharmaceutical clinical trial, the authors of a forthcoming article for ACRP’s Clinical Researcher journal discovered through an in-depth analysis of federally mandated reports on payments for such research projects. In all, 80% of the nearly 37,600 PIs who were active in drug studies for some period within the 2018, 2019, and 2020 timeframe ran just one to five trials with industry funding in that three-year block.
“Estimates about the size and composition of the PI pool in the U.S vary widely and are often based upon rather opaque sources,” said Harold E. Glass, MSc, PhD, cofounder of SunshineMD, a site selection consultancy firm in Philadelphia, Pa., and lead author of the article due to appear in the December 2022 issue of Clinical Researcher. “The federal Sunshine Act mandates the public reporting requirements for all pharmaceutical and medical device companies regarding their payments to U.S. physicians and other medical professionals. This includes separately indicated payments for industry-sponsored clinical research.”
According to Glass, who is also a retired professor at the University of the Sciences in Philadelphia, the database used to capture and report these data, Open Payments, requires extensive user coding and cleaning. However, when the effort was made, he and his coauthor, Andy Guy, MBA, another cofounder of SunshineMD, found that the largest 20 pharmaceutical companies (by spending) account for nearly three-quarters of all payment value, and that the actual number of U.S. PIs conducting one or more pharmaceutical trials has remained strikingly consistent across the industry in recent years—at 28,292 in 2014, the first year of full reporting for the database, and at 26,115 in 2020. Read more …