Clinical Trial Industry Urged to Tackle PI ‘One and Done’ Problem

Christina Brennan, MD, MBA, CCRC, Vice President of Clinical Research, Northwell Health

Chronic principal investigator (PI) turnover and shortages will continue to hold the clinical trial industry back until we do a better job educating and training vital new entrants, says Christina Brennan, MD, MBA, vice president for clinical research at Northwell Health Feinstein Institute for Medical Research. “It’s a real problem in our industry.”

The so-called “one and done” PI phenomenon—in which a new PI conducts one study and then decides not to take on a second study—is a serious issue for the clinical trial industry. A 2014 study by the 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.

“We have a tendency as an industry to rely too heavily on the same reliable PIs,” Brennan says. While this is understandable in the short term, “we won’t be able to move forward without engaging new PIs,” she adds.

Acknowledging the challenge is deep-rooted and tenacious, Brennan nonetheless sees rays of optimism when she looks into the clinical trial landscape’s crystal ball. For example, ACRP’s Functional Competency Guidelines for Principal and Sub Investigators should help slow personnel churn, she says.

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“Many new PIs don’t realize what they’re in for when they sign up for a trial,” Brennan explains. ACRP’s guidelines will make it easier for new entrants to take an “eyes wide open” approach when contemplating clinical trial involvement, she notes, adding that “they’ll know what they’re getting into” in terms of time and financial commitments.

Too often, new PIs don’t realize the time they’ll need just to handle administrative and data signoff issues during a trial, Brennan notes. She also says new PIs don’t always understand they’re probably better off being a junior partner in a trial with an experienced PI on their first go around, or that they might want to focus on post-marketing or observational trials at first, as opposed to more complex trials of investigational new drugs.

In addition to tools like competencies, Brennan believes new technologies will continue to reduce the administrative side of the time burden for PIs. She also believes the industry needs to do a better job of promoting the virtues of clinical trial involvement to PIs. “We remind them it will help them become thought leaders in the industry, offer potential new treatments for their patients, and open new revenue streams” even as it improves healthcare for all, she says.

Author: Michael Causey