Female patients around the country are treated with high-risk medical devices each day, but when the clinical trials that got those implants on the market studied mostly men, how can women be sure of their safety and effectiveness? That's the question facing doctors across the U.S., and the FDA is considering revising its device study guidance to boost the representation of women in trials, The Day reports.
Take implantable cardioverter defibrillators, for example. Much of the data doctors use to prescribe the devices is largely focused on male test subjects, and, even then, the results aren't reported by sex, so any adverse events specific to women aren't disclosed, Rita Redberg, a University of California, San Francisco professor, told The Day. As a result, not until 2009 did physicians realize that ICDs proved no more effective than drugs in female patients, Redberg said.
The FDA is considering revising its recommendations on trial enrollments, looking to improve female representation in medical device studies with guidelines expected to be approved this year. However, those recommendations would be nonbinding, The Day reports. Even if those guidelines were made mandatory, the majority of devices are cleared through 510(k), meaning they are declared substantially equivalent to techs approved using old, male-dominated data.
The advocacy group Society for Women's Health Research (SWHR) is asking the FDA to make its recommendations into rules, requiring devicemakers to include more women in trials and report reactions and adverse events by sex. "There's still only 30 percent--maybe up to 40 percent--of women involved in clinical trials, and too often their data isn't analyzed separately from men's," Christine Carter, SWHR vice president, told The Day.
- read The Day's report
- check out the FDA's draft guidance on women's participation in clinical trials