FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

CDER’s Latest Clinical Trial Snapshot Reports Fewer Trial Participants

Feb. 12, 2019

CDER released its fourth annual Drug Trials Snapshots report, which shows a significant drop in the number of participants in pivotal novel drug trials that led to agency approvals.

The overall number of participants dropped by more than half from approximately 106,000 in 2015 to 44,000 in 2018, according to the latest report.

Another significant trend was a shift in the trial demographics towards inclusion of more female and black or African American participants. The overall percentage of women increased from 40 percent in 2015 to 56 percent in 2018, while black participation doubled from 5 percent in 2015 to 10 percent in 2018. Hispanics were not recorded in the first two snapshot reports, but accounted for 14 percent in 2017 and 2018.

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