Posted by Michael Wonder on 13 Mar 2017
Review of the drug trials snapshots program of the US FDA: women in cardiovascular drug trials
13 March 2017 - Over the last 20 years, there have been concerns that too few women and minorities are enrolled in clinical trials to provide confidence about drug safety and effectiveness.
Women’s advocacy groups, in particular, have called for more representation in trials of cardiovascular diseases. In 2012, the US FDA Safety and Innovation Act (FDASIA 907) was enacted and required the FDA to report on the diversity of participants in clinical trials and the extent to which safety and effectiveness data are based on demographic factors such as sex, race, and age. In response, the FDA piloted a new transparency initiative called the Drug Trials Snapshots Program.
Snapshots are data posted online in a standardised format after approval of a “new molecular entity” (NME). They show who participated in the pivotal clinical trials used to approve the drug by sex, race, and age subgroups. Snapshots also provide statements on observed demographic subgroup differences in safety and efficacy. The FDA releases a Snapshot for every NME approved after January 2015 within 30 days of the approval date.
