Drug Trials Snapshots

https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has released the 2025 Drug Trials Snapshots (DTS) Summary Report. The report summarizes CDER’s 2025 DTS program, which captures the demographic groups represented in the clinical trials that supported the 46 novel drug approvals in 2025. Overall, approximately 26,000 patients participated in these trials. The summary provides a percent participation of demographic groups by sex, race, ethnicity, age group, and U.S. participation for each of the approved novel drugs. CDER created the DTS transparency initiative in 2015 to report on the representation of participants in clinical trials and, to the extent possible, to summarize the safety and effectiveness data by sex, age, race, and ethnicity. For more information about the DTS program, please contact Snapshots@fda.hhs.gov.