2023 Drug Trials Snapshots Summary Report

https://www.fda.gov/media/178602/download?attachment=&utm_medium=email&utm_source=govdelivery Yesterday, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released the 2023 Drug Trials Snapshots Summary Report. The report summarizes CDER’s 2023 Drug Trials Snapshots (DTS) program, illustrating the demographic groups represented in the clinical trials for the 55 novel drugs approved in 2023. The summary provides a percent participation of demographic groups by sex, race, ethnicity and age for each of the approved novel drugs. Overall, 44,000 patients participated in these trials. New this year, the report highlights male and female participants by therapeutic area and percentage of participants within the U.S. CDER created the DTS transparency initiative in 2015 to report on the diversity 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.