FDA Report Highlights Importance of Clinical Trial Participants Outside United States

Demonstrating the increasingly international flavor of clinical trials, a new report from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) found nearly two-thirds of participants in clinical trials that supported U.S. drug approvals from 2015 to 2019 came from outside the United States.

Of the almost 300,000 study participants tracked in the program, the U.S. led with 102,506 people in trials, followed by Poland, Germany, and Russia with high numbers as well.

California produced the most trial participants for the period in the United States, followed by Florida and Texas. Female participation in trials was higher in the U.S., at 56%, versus 49% in the aggregate elsewhere.

The CDER report found that most Black or African American participants were from U.S. sites. In the U.S., 16% of trial participants were Black or African American, as compared to only 2% in the rest of the world for trials supporting U.S. drug approvals, which lowers the global participation rate for this racial group to just 11%.

Race distribution by age was similar, but the proportion of Black or African Americans in the 65-and-older age group was 6% lower.

Edited by Michael Causey