By Jim Kremidas, executive director, Association of Clinical Research Professionals (ACRP)
It’s ruefully referred to throughout the clinical trial industry as the “one and done” phenomenon, and it’s a problem that has plagued us for years. The term refers to physicians and other medical professionals who jump into a trial to assume the duties of principal investigators (PIs). Unfortunately, many are completely or relatively inexperienced in clinical trials; they’ve taken on the role of PI in hope of adding a new revenue stream to their practice or boosting their academic credentials.
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 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.
Both revenue and credentialing are completely understandable motivations. But we must demand more. We also must help prospective PIs better understand exactly what they’re signing up for.
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.
Result? They struggle to complete their portion of the trial and drop out. Sometimes they drop out even before the trial concludes. It’s wasteful, it damages clinical trial quality and integrity, and it shortchanges the very patients trusting us to help them find the drugs and devices that can improve their quality of life and, in some cases, save those lives.
There are several other forces driving PI churn. Trial protocols are increasingly complex, sponsor demands are increasingly onerous, and regulators continue to raise the bar for study conduct. Minus clear, industrywide 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.
At ACRP, we’re working to further professionalize the clinical trial workforce. For example, in January 2018 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 road map by which individuals and organizations can support the hiring, assessment, and development of entry-level through senior CRCs.
Variance is the enemy of quality. Before we turned our attention to PIs, we decided to join other industry leaders to attack the ad hoc manner in which we hire and train CRCs. This is a root cause of poor quality and inefficiencies in clinical research conduct from the beginning to the end of the trial life cycle — a span for which PIs take on full responsibility by signing Form FDA 1572 (Statement of Investigator) to receive FDA approval to conduct their trials. We are also failing those at the front lines of clinical research by leaving them without an industrywide consensus on what we expect from them and how they can grow in their careers.
We are developing PI guidelines with same goal: to ensure they receive the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research community.
There’s another issue people sometimes find difficult to address in a meaningful way: PI compensation. Just as the actual work is often treated as a “one size fits all” undertaking, so, too, are compensation structures. It’s important to treat each situation separately and adjust the compensation accordingly. This is another area where we believe industry guidelines could be helpful.
Members out in the field tell us that an array of factors appear to address some aspects of compensation in a seemingly random way. For example, in some cases, a PI might not receive payment for his or her work in site selection and initiation, study protocol meetings, ongoing trial oversight, subject visits, review of adverse events, review of laboratory reports, and monitoring visits. Yet, in other cases they are compensated. It’s not always clear what logic is driving the determination.
Complex and not always synchronized federal and state laws further complicate matters. For example, 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 impact PI compensation programs.
As Suzanne Rose, Ph.D., director of the Office of Research for Stamford Hospital, told attendees at our ACRP 2018 Conference, “People...about [PI compensation a lot] it, but don’t give a lot of detail.” “I’m not sure why we’re afraid” to examine it more closely, she added.
Indeed, there are several significant challenges we must work together as an industry to address. I’d put the PI “one and done” phenomena near the top of any priority list.
I urge you to connect with us at ACRP as we work with representatives from the entire clinical trial spectrum to bring patients the high level of results they expect and deserve.
Please reach out to me at firstname.lastname@example.org with your thoughts and become part of the answer to this vexing challenge.
About The Author:
Jim Kremidas is the executive director for ACRP, a not-for-profit association that represents the clinical research enterprise. Previously, he provided consulting services including support for investigator sites, academic institutions, sponsors, and suppliers. He was SVP of patient recruitment at two large CROs for over six years, during which he and his teams were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company, including in leadership roles in clinical trial patient recruitment and retention, outsourcing of clinical development projects, selection and establishment of relationships with direct-to-consumer and professional advertising agencies, and implementation of standardized processes for the development of marketing materials. He is on the advisory board of the Center for Information and Study on Clinical Research Participation (CISCRP) and is also a volunteer for the Clinical Trials Transformation Initiative (CTTI).