Now Available: 2019 Drug Trials Snapshots Summary Report

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Now Available: 2019 Drug Trials Snapshots Summary Report

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a report titled “2019 Drug Trials Snapshots Summary Report.” The report summarizes CDER’s 2019 Drug Trials Snapshots program, highlighting the 48 novel drug approvals of 2019, by illustrating the demographic groups represented in the clinical trials for these novel drugs. Overall, 46,391 patients participated in these trials. The summary provides an overall participation of demographic groups followed by a more detailed summary table of the representation by sex, race, ethnicity and age for each approved drug, as well as the tables per selected therapeutic areas with most approvals in 2019. Similar summary reports of Drug Trials Snapshots were released by CDER in 2019, 2018 and 2017.

Every year, CDER approves novel drugs based upon review of safety and efficacy measures from sponsor submitted clinical trial data. In recent years, the representation of certain subgroups such as women and people of racial minority groups has become of greater interest to the public. CDER created the Drug Trials Snapshots transparency initiative to report on the diversity of participants in clinical trials and the extent to which safety and effectiveness data is based on demographic factors such as sex, age, race and ethnicity. Of note in this year’s summary report, 72 percent of the participants were women.

Drug Trials Snapshots are data posted online in a standardized format after approval of a novel drug that is either a New Molecular Entity (NME) or original biologic (BLA) product. They show who participated in the clinical trials and provide statements on whether there were any observed differences in safety and efficacy by demographic subgroups at the time of approval. Since January 2015, CDER has published a Drug Trial Snapshot for each novel drug approved within one month of the official approval date.

For more information about the Drug Trials Snapshot program, please contact Snapshots@fda.hhs.gov.