Is Certification Key to Stemming the PI ‘One and Done’ Phenomenon?

One and Done PIs

“I’m really shocked” at the chronic lack of certification requirements in the clinical trial industry, says Randall R. Stoltz, MD, CPI, a medical director with Covance. “There are certifications for other healthcare workers and different information technology roles, for example, but you don’t have to be a certified clinical trial practitioner even though your work impacts the lives of people,” he says. “It’s really incredible.”

While Stoltz doesn’t want to label himself a pessimist, he allows he’s disappointed at the pace of certification adoption in wide swaths of the clinical trial space. “I actually thought 10 years ago the Food and Drug Administration [FDA] would mandate certification because of all the violations” of the agency’s Statement of Investigator (Form 1572) and the many FDA-issued Warning Letters received by principal investigators (PIs) for poor trial conduct, he says.

Ignorant PIs who blithely sign the FDA-demanded Form 1572 run the risk of falling into serious trial deviations or even potential legal issues.

“[T]he CPI certification is a valid differentiator in predicting regulatory compliance as investigators obtaining certification perform better on FDA inspections than those investigators who are not CPI certified.”

That’s just one example of recently published research connecting ACRP Certification with improved clinical trial quality. See More >>

Stoltz applauds organizations such as the Association of Clinical Research Professionals (ACRP) for working with FDA and others to elevate the role of certification. “It doesn’t have to be elaborate or exotic,” he notes, “but we need some kind of training [with] a minimum number of hours…to show you know what you’re getting yourself into” when planning to work in human subjects research. Further, he’s a fan of having sub-investigators working alongside PIs so they can learn from one another.

Lack of certification and clarity contributes to the so-called “one and done” phenomenon plaguing the PI role in clinical trials. A 2014 study by Tufts Center for the Study of Drug Development counted some 40,000 PIs, with half being new to the job. In addition, although the highest turnover rates are observed among the least active investigators, turnover rates have been getting progressively worse among more active investigators.

It’s not a surprising scenario to Stoltz. Too many wannabe PIs don’t understand the demands of the role, he says. “They think they’re going to make a ton of money,” he notes, “then they find out if they don’t actually do it right, they’re losing money.” That kind of churn makes for longer, less efficient clinical trials, experts agree.

Author: Michael Causey