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March 3, 2011

Heart Device Studies Exclude Women, Research Reveals

Many heart device studies conducted to gain approval from the US Food and Drug Administration (FDA) do not include enough women, research reported in Circulation: Cardiovascular Quality and Outcomes has warned. Researchers reviewed 123 studies contained in the pre-market appro

By cms admin

Many heart device studies conducted to gain approval from the US Food and Drug Administration (FDA) do not include enough women, research reported in Circulation: Cardiovascular Quality and Outcomes has warned.

Researchers reviewed 123 studies contained in the pre-market approval applications for 78 high-risk cardiovascular devices approved by the FDA between 2000 and 2007.

The review showed that 28% of the studies did not report the gender of the participants, and in cases where it was reported, men represented an average of 67% of study participants.

In 1994, the FDA instituted a policy stating that all submissions seeking approval must contain a gender-bias statement explaining whether the proportion of men and women in the study reflects the proportion of men and women who have the condition.

The FDA also requires all the submissions to contain differences in the safety and effectiveness of the device in women.

The required gender-bias statement was present in only 41% of the reviewed studies.

Among studies that included the statement, only 26% reported differences in device safety or effectiveness between men and women.

In addition, between 2000 and 2007, the proportion of women enrolled in studies or the number of successful applications that included the gender-bias statement did not increase.

Senior author of the study Rita Redberg said that failure to include women in clinical trials has been a big problem for a long time and it is not improving, and further action is needed.

“Strict enforcement of the current requirements is required, including sending applications back without review until the required statements are submitted,” Redberg said.

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