One of the big things her experience as director of the Office of Research for Stamford Hospital has taught Suzanne Rose, MS, PhD, CCRC, is that the business of compensating principal investigators (PIs) for their involvement in clinical trials is not a “one size fits all” undertaking.
“Every study is different, every site is different, every sponsor is different, every physician is different,” she told attendees at her ACRP 2018 presentation today (April 29) on “How Should Sites Compensate Investigators?” “I really recommend taking an individualized approach to every [compensation agreement].”
Depending on many different factors, Rose said a PI may or may not be compensated for activities tied to site selection and initiation for a sponsored study, the investigator meeting to go over the study protocol, ongoing oversight of the trial, subject visits, review of adverse events and serious adverse events, review of laboratory reports, monitoring visits, site phone calls, and the site close-out visit.
Walking her audience through some of the complexities in U.S. law that affect how, when, and for what activities PIs will be compensated, Rose touched on such considerations as the Anti-Kickback Statute and its “Personal Services Safe Harbor” agreement in criminal law; the Stark Law, which is part of the Social Security Act, and its “Personal Services Exception”; and the civil statute known as the False Claims Act.
It’s surprising, Rose said, that PI compensation is so complicated, yet very little data exists on the topic in the literature. Anecdotally, her estimate is that anywhere from 11% to 25% of a total study budget is typically consumed by this compensation. “People talk a lot about it, but don’t give a lot of detail,” she noted. “I’m not sure why we’re afraid” to examine it more closely, she added.
In any event, from her involvement in PI compensation over time, Rose offers these tips for success in physician negotiations:
- Keep them involved in the study budget negotiation process from early in the game.
- Treat each study as a new negotiation.
- Establish reasonable reimbursement in terms of dollars per visit, dollars per fee, or percentage of the budget.
- Approach all of the study’s financial matters as an “open book.”
- Pay the agreed-upon compensation quarterly and on time.
- Conduct invoicing for the compensation process.
Author: Gary Cramer