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Heart Devices Not Tested Enough in Women: Study
Date:3/1/2011

disease was gaining unprecedented attention, there was no increase in the proportion of women participating in studies or the number of applications with gender-bias statements, Redberg said.

FDA summaries of 28 percent of the studies made no mention of gender. Of those that did, men made up 67 percent of the study participants, the researchers found.

In addition, only 41 percent of the studies included the required gender statement. Of these, 94 percent showed results by sex, and 26 percent found sex-related differences in the safety and effectiveness, the researchers found.

Only 11 percent of the studies without gender-bias statements included any performance data related to gender difference. Studies of fewer than 50 patients were not included in the sex-based analysis, the authors noted.

Among applications the agency approved, device makers erroneously excluded women from studies, the researchers found. Some manufacturers understated the number of women with a specific heart condition. Other times, they said their study included an equivalent number of women as earlier studies, without acknowledging that those prior studies included only a token number of women.

Since data are not available about devices that the FDA didn't approve, Redberg's team couldn't determine how many of these included gender data.

The FDA, meanwhile, says it is working to correct these shortcomings.

"The findings reported in this study are not new," said FDA spokeswoman Karen Riley. "FDA is aware of the under-representation of women in clinical trials," she added.

Recently, the FDA division that approves medical devices has come under fire from the medical community for approving devices too fast without proper data, while device manufacturers complain it doesn't approve devices fast enough and over-complicates the process.

The agency's own 2009 study found that women, children and minorities were underrepresented in premark
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