• One And Done: How Bad Is The PI Turnover Problem?

    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.


Jim Kremidas

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).