FDA Issues Summary Report on Global Participation in Clinical Trials: 2015-2019
Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) released a report titled Global Participation in Clinical Trials: 2015-2019. The report summarizes CDER’s Drug Trials Snapshot program by illustrating the demographic groups represented in the clinical trials for new drug approvals from 2015-2019. Overall, almost 300,000 patients participated in these trials, and 35 percent were from the United States (U.S.). The summary provides an overall participation of each demographic group globally and within the United States followed by participation trends over the 5-year span and by therapeutic areas. CDER released past annual summary reports of Drug Trials Snapshots, but this is the first summary report to cover five years’ worth of DTS data.
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 the 102,596 U.S. participants: 56 percent were women, 16 percent were Black or African American and 21 percent were 65 years and older. Also, therapeutic areas with the highest numbers of participants include: cardio-vascular, endocrine/metabolism and oncology/hematology.
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.
Relatedly, on December 16, 2020, CDER will host a webinar on “Diversity in Clinical Trials.”
Topics covered in this webinar will include: FDA guidance that supports diverse participation in clinical trials, status of trial diversity after 5 years of Drug Trials Snapshots reporting and FDA’s efforts that support clinical trial diversity. If you’d like to attend, please register in advance.
For more information about the Drug Trials Snapshot program, please contact Snapshots@fda.hhs.gov.
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