Ep. 39: Recruiting and retaining experienced principal investigators

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The success or failure of clinical trials is dependent in large part on the engagement of the principal investigator (PI). PIs play an important role in trial selection, site activation, and study execution. This includes but is not limited to, the development and implementation of a strategy to maximize enrollment, optimize data quality, and ensure patient retention. The legal, regulatory, financial, and workload burden for site PIs has grown considerably over time. The benefits of serving as a site PI are becoming less evident. As a result, increasing dissatisfaction exists among physicians contributing to trials resulting in decreasing interest in trial participation. According to the Tufts Center for the Study of Drug Development (Tufts CSDD) just over 32,000 active principal investigators are operating worldwide (as of Dec 2021). This number continues to grow but at a slower overall rate of 1.5% annually during the most recent 10-year period (2010 – 2020) compared to 4.6% annually in the prior decade. However, the number of FDA-registered studies during this same 10-year period grew at an average annual rate of 7%. In this episode, Dr. Gerald Y. Minuk, Professor Emeritus at the University of Manitoba in Winnipeg, Canada, and CEO of Refuah Solutions will share his recommendations to ease the burden of the principal investigator and support the growth of these important leaders of clinical research.