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Heart Association Calls for More Research on Gender Differences

Only one-third of subjects in cardiovascular trials are women

American Heart Association (AHA) President Mariell Jessup, MD, has issued a statement in support of a new report, “Sex-Specific Medical Research: Why Women’s Health Can’t Wait,” released March 3 by the Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital.

“While many Americans may think heart disease is a man’s disease, it is in fact the No. 1 killer of women, and sometimes affects them in different ways,” Jessup said. “Yet, as this helpful new report points out, only one-third of participants in cardiovascular clinical trials are women, and fewer than 31% of trials with women report outcomes by gender.”

Jessup noted that even though the new report chronicles progress in the fight against heart disease, it correctly underscores that more research about how gender affects the health of women is needed, especially when it comes to heart disease.

“That’s why this report is such an important contribution to the conversation about putting an end to disparities in research,” Jessup remarked. “Without such efforts, we not only do women a disservice, we also put the health of all Americans at risk because we miss out on opportunities to better understand disease.”

The AHA worked with Congress and other leading patient and women’s groups to get Section 907 of the Food and Drug Administration (FDA) Safety and Innovation Act enacted into law in 2012. As a result, the FDA is now working to develop an action plan that addresses gaps in the participation of women, minorities, and the elderly in clinical trials; the analysis of gender and other subgroup differences; and the availability of subgroup-specific data to clinicians, researchers, and patients.

Jessup urged the FDA to adopt the report’s recommendations.

Source: AHA; March 3, 2014.

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