Magazine Article | November 8, 2017

More Gender-Based Analysis Needed In Medical Device Studies

Source: Life Science Leader

By Ann Neuer, Contributing Writer

New research from Yale and the University of California San Francisco reveals that few medical devices are analyzed for the impact of gender on safety and effectiveness. It is widely known that women, as well as elderly and minority populations, have long been underrepresented in clinical trials for drugs and biologics, but as reported in JAMA Internal Medicine, a new study found a similar pattern when it comes to evaluating medical devices. The researchers reviewed 82 studies filed in 2015 with the FDA in support of premarket approval for original medical devices. Of the 77 studies that included both men and women, only 17 percent were analyzed by sex.