Thursday, February 11, 2021

2020 Drug Trials Snapshots Summary Report - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

2020 Drug Trials Snapshots Summary Report

The U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) released a reporttitled 2020 Drug Trials Snapshots Summary ReportThe report summarizes CDER's 2020 Drug Trials Snapshots program, highlighting the 53 novel drug approvals of 2020 by illustrating the demographic groups represented in the clinical trials for these novel drugs. Overall, 32,000 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 for selected therapeutic areas with the most approvals in 2020.  

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 publicCDER created the Drug Trials Snapshots (DTS) 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, 56 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 application (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. Similar summary reports of Drug Trials Snapshots were released by CDER in 2019, 2018 and 2017.  

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


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