FDA's 2018 Drug Trials Summary Report now available
Today, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released a report titled “2018 Drug Trials Snapshots Summary Report.” The report summarizes CDER’s 2018 Drug Trials Snapshot program, highlighting the 59 novel drug approvals of 2018, by illustrating the demographic groups represented in the clinical trials for these novel drugs. In 2018, 43,966 patients participated in clinical trials for the 59 approved novel drugs. The summary provides an overall average of demographic groups followed by a more detailed summary table of the percent representation of sex, race, ethnicity and age groups participating in the clinical trials used to approve each novel drug. Similar summary reports of Drug Trials Snapshots were released by CDER in 2017 and 2018.
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 a transparency initiative called the Drug Trials Snapshots 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.
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 pivotal 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.