March 1st, 2011

CV Device Trials Still Fail To Include More Women

Women continue to be significantly underrepresented in trials of cardiovascular devices, according to a study published in Circulation: Cardiovascular Quality and Outcomes. Sanket Dhruva and colleagues performed a systematic review of the PMA applications for 78 high-risk cardiovascular medical devices submitted to the FDA from 2000 to 2007.

Despite repeated attempts to call attention to the issue and institute changes by various government and medical organizations like the NIH, FDA, and the AMA, the investigators reported that most studies failed to include enough women to adequately assess the safety and efficacy of the devices in women. Where the information on gender distribution was available, men composed two-thirds of the study populations, with no increase in the proportion of women observed over time.

“Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work,” said Rita Redberg, the senior author of the study, in an AHA press release. “We found no encouraging trends. Failure to include women in clinical trials has been a big problem for a long time and it isn’t improving, so further action is needed.”


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