The FDA has issued a draft guidance to address the underenrollment of women in medical device clinical trials.
The agency says the objectives of the guidance are to better communicate the balance of risks and benefits of FDA-approved or cleared medical devices; determine sex-specific questions for further study; and encourage the consideration of sex and associated covariates--including body size and plaque morphology--during the trial design stage, according to the draft.
As the agency notes in a statement, certain medical products may elicit different responses in women than in men due to such factors as genetics, hormones, body size, diet and sociocultural issues. In addition, certain variables associated with women, such as size or certain illnesses, may be responsible for gender differences observed in the safety and effectiveness of medical devices.
The agency also points to a 10-year-old Government Accountability Office report on FDA-reviewed drug trials which found that women represented 52% of enrollees. However, 30% of study documents did not report outcomes by sex and nearly 40% didn't report enrollment demographics. A later study of cardiovascular device pre-market applications showed that pivotal trials that reported sex enrolled an average of 33.9% women.
"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," according to CDRH Director Jeffrey Shuren. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."
The FDA is seeking stakeholder input on the draft guidance during a 90-day public comment period.
- read the FDA's statement
- check out the FDA's draft guidance