Principal Investigators Take the Lead FDA-Regulated Studies

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Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-05-01-2013, Volume 22, Issue 5

Tufts CSDD

The total number of active principal investigators (PIs) participating in FDA-regulated studies worldwide has reached a record high of 27,924 due to rising clinical trial volume and more individual sites conducting fewer trials each year. More than half (53%) of all FDA-regulated clinical trials are now conducted by independent, community based PIs—the first time this segment has taken the leading proportion globally. University, hospital, and government clinics have been gradually losing their market share—falling from about two-thirds of all global FDA-regulated investigators in 2006 to less than half (47%) of the total in 2012.

Figure 1. The percentage of community-based investigators is growing worldwide.


Tufts Center for the Study of Drug Development,