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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
