Apr 25, 2023
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.