Clinical Trial Industry Must Confront Principal Investigator Challenges

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

It’s time for stakeholders in the clinical trial industry to band together and do a better job of identifying new principal investigators (PIs) to take pressure off existing PIs and further advance clinical trial quality and efficacy, says Christina Brennan, MD, MBA, CCRC, vice president of clinical research at Northwell Health.

“Too often, we [keep going] to the same pool of existing PIs, but we have to find ways to bring new PIs in and mentor them so they remain in the industry,” Brennan says.

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.

Brennan and others are calling on the clinical trial industry to do a better job in the “care and feeding” of new PIs. For example, “we too often put them in ‘sink or swim’ situations’” with demanding and complex trials on their first time out, she notes. Instead, she suggests training fledgling PIs as sub-investigators and/or getting them started with relatively easier trials such as those conducted for post-marketing efforts.

However, training won’t be effective if it’s treated as a “one size fits all” situation, Brennan warns. Effective training must be customizable to the skills required and how a given student best learns, she says.

“Some like virtual training, some like more on-the-job training,” Brennan adds. “[But] I can’t overemphasize the importance of promoting adult learning as a way to address the ‘one and done’ problem.”

Author: Michael Causey