Drug Trial Snapshots Summary Report – from 2015 to 2019

On 9 November 2020 the FDA announced the availability of a five-year summary and analysis of clinical trials participation and demographics.

Beginning in 2015, and in response to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA 907), the FDA’s Center for Drug Evaluation and Research (CDER) has been reporting clinical trial demographic data for new molecular entities and original biologics through the Drug Trials Snapshots (DTS) program. Individual drug trial snapshots and annual summaries have been provided on the FDA website for the past five years. This summary report aggregated demographic data from DTS snapshots published between 2015 and 2019.

According to the Center for Drug Evaluation and Research (CDER) Drug Trials Snapshots (DTS) Summary Report 2015–2019, the U.S. accounted for 35%, or 102,468 out of a total of 272,766 participants, followed by Poland, Germany and Russia with 4% each and Japan, Canada and the Czech Republic at 3%.

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