FDA Report Shows Growth in Clinical Trial Participation Among Women, African Americans

FDA's Drug Trial Snapshots Report

A new report from the U.S. Food and Drug Administration (FDA) suggests there has been some improvement in terms of advancing diversity in clinical trial research, though recent reports suggest more work remains to be done.

In 2016, FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).

Overall, 31,468 patients participated in these trials. Of that population:

  • Nearly half, or 48%, were women
  • More than three-quarters, or 76%, were white
  • The African American population was 7% and the Asian population was 11% (there was no specific breakout for Hispanic/Latino Americans)

By contrast, 2015 was more active overall. That year, CDER approved 45 novel drugs, either as NMEs under NDAs or as BLAs. Overall, 105,826 patients participated in that set of trials. Of that population:

  • Less than half, or 40%, were women.
  • More than three-quarters, or 79%, were white.
  • The African American population was 5% and the Asian population was 12%

More than 235,000 people have visited the FDA’s Drug Trials Snapshot website since it was launched in January 2015. The website is part of FDA’s effort to make demographic data of clinical trial participants more available and transparent. The top five drug snapshots visited were Jubila, Lonsurf, Savays, Kybella, and Cosentyx respectively.

Author: Michael Causey