Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014. This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance of an expansion of the program to include all new molecular entities subject to an approved NDA beginning in 2015.
The Drug Trials Snapshot website was developed by FDA in response to the requirements in Section 907 of FDASIA that FDA: 1) report to Congress on certain information regarding clinical trial participation by demographic subgroups and subset analysis of the resulting data; and 2) address the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups is included in applications submitted to FDA. In response to these requirements, FDA developed an action plan that included the publication on FDA’s website of demographic composition data and the resulting analysis by subgroup in pivotal clinical studies for FDA-approved medical products.
The initial pilot includes demographic subgroup information and related analyses for the following products: Dalvance (dalbavancin hydrochloride, acute bacterial skin and skin structure infections); Entyvio (vedolizumab, Crohn’s disease); Entyvio (vedolizumab, ulcerative colitis); Jublia (efinaconazole, onychomycosis); Sivextro (tedizolid; acute bacterial skin and skin structure infections); and Zontivity (vorapaxar, myocardial infarction and peripheral arterial disease).
Interested parties have until January 23, 2015 to submit comments electronically at http://www.regulations.gov or to submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.