17 Jun Study: Women underrepresented in clinical trials of medical devices

By Jeff Craven, Regulatory Focus

Women are underrepresented in clinical trials of medical devices and are significantly underrepresented in clinical trials evaluating cardiovascular devices compared with devices in other specialties, according to a systematic review published in JAMA Internal Medicine.

While women’s representation in drug trials has improved, the authors said, their representation in medical device trials has not. In 2014, the US Food and Drug Administration (FDA) published a final guidance document outlining sex-specific considerations for medical device clinical studies, including recommendations to more accurately reflect the intended population of the device. The Center for Devices and Radiological Health (CDRH) also made representation of women in clinical trials of medical devices part of a CDRH Health of Women Program strategic plan in 2022.

The problem of enrolling a representative proportion of women persists in clinical trials of medical devices, according to Nitzan Karny Epstein of the infectious diseases unit at Meir Hospital in Kfar-Saba, Israel, and colleagues. Read more…