• 18
  • June
    2012

According to recent medical reports, a significant portion of the population is dramatically underrepresented in certain kinds of clinical trials. Specifically, women are underrepresented in trials aimed at testing the safety of medical devices.

This representation problem is significant. First, a potentially defective medical device may not manifest as defective in men, but could ultimately manifest as defective or otherwise dangerous in women. If women are not adequately represented in medical device clinical trials, they may suffer dire safety consequences when implanted with the devices later on.

Even when women are represented in studies, the results of said studies are not generally broken down according to sex. This lack of valuable information is frustrating for physicians who need a clear sense of how a device will work in their female patients before they implant one.

Respected cardiologist and professor of medicine at the University of San Francisco Rita F. Redberg has emphasized that "The time to collect data in both sexes is before FDA approval. Especially with implanted devices, where there's no going back."

Roughly 20 years ago, the FDA put standards in place aimed at improving the representation of younger adult women in clinical drug trials. Until that point, women of childbearing age were explicitly barred from participating in the majority of studies.

Similarly, the FDA has recently proposed guidelines aimed at improving this situation. However, the guidelines will likely not be finalized until the end of the year. Until then, the lack of female representation in medical device clinical trials will continue to affect the safety and quality of care that women receive.

Source: Middletown Press, "FDA: Enroll more women in medical device trials," Rochelle Green, Jun. 8, 2012