Principal Investigators Take the Lead FDA-Regulated Studies
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, https://csdd.tufts.edu.
Merck Stops HYPERION Trial for Winrevair in PAH Following Positive ZENITH Trial Results
January 30th 2025The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the efficacy of Winrevair (sotatercept-csrk) in treating pulmonary arterial hypertension, making it unethical to continue.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
