FDA Wants More Women Participating in Post-Approval Studies

The U.S. Food and Drug Administration (FDA) is mandating the inclusion of women in post approval studies for medical devices. According to FDA officials, female participation is necessary to reduce any gender bias related to safety and effectiveness of devices.

A  peer reviewed study by the FDA illuminates the importance of woman participation and analysis of sex differences in post approval studies (PAS) in the Journal of Women’s Health.

According to researchers, women may react differently to the medical devices, based on such factors as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. Women also could help better assess a device’s benefits as well as its potential adverse effects.

The study found that cardiovascular, orthopedic, renal and urologic devices have less than 50 percent PAS participation by women, and female inclusion in post-approval analyses for all devices cleared since 2001 has hovered between 30 percent and 37 percent. In cardiovascular PAS, female participation varied by type of device and was consistent with the prevalance of conditions the products were designed to treat; aortic aneurysms, for instance, occur more frequently in men while septal defects are found in more women.

Ophthalmic device studies showed a higher than 50 percent enrollment for women — an interesting finding most likely attributted to the high number of PAS-required devices designed for older adults (intraocular lenses for aphakic patients, for example). By the same token, the plastic and reconstructive device studies also had a higher level or female participation due — not surprisingly — to the higher number of women undergoing cosmetic procedures.  

“Imbalanced participation by sex in clinical trials has resulted in an inequality in the understanding, diagnosis, and treatment of diseases between the sexes. Therefore, FDA will not only continue tracking, but will encourage the enrollment of women in clinical studies,” the study authors stated in their Journal article. “Additionally, FDA will continue to update medical device labels with information on health and safety benefits and risks obtained during the conduct of PAS, including sex-specific information. FDA will work with applicants to develop PAS that enroll and retain proportions of women that are consistent with the sex-specific prevalence for the disease or condition the device is used to treat. If there are sex-specific signals in the premarket studies or there are known sex differences that impact safety and effectiveness, the FDA may encourage targeting investigational sites where necessary subpopulation recruitment can be more easily facilitated. Tailored communication strategies, community involvement, and flexible follow-up schedules can also increase participation of women.”

The importance of female participation in PAS studies cannot be overlooked, according to the experts in this field. “It is critically important that we have adequate participation of women in clinical trials, and that we analyze sex differences in study outcomes and adverse events,” said Susan G. Kornstein, M.D., executive director of the Virginia Commonwealth University Institute for Women’s Health, in a news release.