Women Underrepresented in Heart Device Studies March 1, 2011 -- Despite federal mandates to include more women in research studies, women are often underrepresented in trials evaluating cardiac stents, implantable defibrillators, and other high-risk cardiac devices.

The findings, which appear in Circulation: Cardiovascular Quality and Outcomes, reflect many of the sentiments expressed in the 2011 update to the American Heart Association’s cardiovascular prevention guidelines for women. The new guidelines call for more male- and female-specific results, especially regarding risks from preventive therapies such as aspirin.

Official efforts aimed at including gender-specific information in studies dates back to 1994, when the Center for Devices and Radiological Health enacted a policy to address gender bias in submission forms for new medical devices. This is the same year that the FDA established the Office of Women’s Heath.

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