Putting “One and Done” in the Rearview Mirror

Clinical Researcher—June 2018 (Volume 32, Issue 6)

EXECUTIVE DIRECTOR’S MESSAGE

Jim Kremidas

[DOI: 10.14524/CR-18-4034]

 

 

It’s called the “one and done” phenomena, and it’s a problem that has plagued the clinical trial industry for years. It refers to physicians and other medical professionals who are would-be principal investigators (PIs), though completely or relatively inexperienced in clinical trials, and who take one on as PI in hope of adding a new revenue stream to their practice or boosting their academic credentials.

Unfortunately for them, and patients, they quickly find conducting a trial isn’t so easy after all. They underestimate the time and personnel needed to get the job done right. So, they struggle to complete their portion of the trial and drop out. Sometimes they drop out before the trial concludes.

There are several other forces at work driving the problem of PI churn. Trial protocols are increasingly complex and sponsor demands increasingly onerous, regulators continue to raise the bar for study conduct, and minus clear, industry-wide standards and certifications, it’s incredibly difficult for prospective PIs to do their homework adequately before they decide to become part of the clinical trial process.

In addition, the standards for compensation are murky. For example, 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, review of adverse events and serious adverse events, review of laboratory reports, monitoring visits, site phone calls, and the site close-out visit.

Recognizing the Challenges

It’s timely that this month’s Clinical Researcher looks at the important role of the PI as we join together to address these challenges and to try and put them in the rearview mirror of the research enterprise.

Evidence of the PI turnover problem abounds. A 2014 study by Tufts Center for the Study of Drug Development counted some 40,000 PIs, with half being new to 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.

At ACRP, we’re working to further professionalize the clinical trial workforce. For example, in January we released the clinical research industry’s first-ever competency guidelines for clinical research coordinators (CRCs), a study team role in which professionalism can make a world of difference for PIs’ capacities to take on and remain engaged in clinical trials. The groundbreaking guidelines provide a comprehensive roadmap by which individuals and organizations can support the hiring, assessment, and development of entry-level through senior CRCs.

Variance is the enemy of quality. The ad hoc manner in which we hire and train CRCs is a root cause of poor quality and inefficiencies in clinical research conduct from the beginning to the end of the trial lifecycle—a span for which PIs take on full responsibility by signing the Form FDA 1572 (Statement of Investigator) to receive U.S. Food and Drug Administration approval to conduct their trials. We are also failing those at the front lines of clinical research by leaving them without an industry-wide consensus on what we expect from them, and how they can grow in their careers.

We hope these guidelines will provide CRCs with the support they need while improving operational quality and trial outcomes for their PIs and for all stakeholders in the clinical research community. And that’s just a start. Watch this space for some exciting new developments throughout the rest of 2018.

Jim Kremidas (jkremidas@acrpnet.org) is Executive Director of ACRP.