Two important developments just happened on the health equity and diversity front.
One, the American Heart Association released a ground-breaking study finding women’s cardiovascular health is perhaps more poorly understood than even those of us working in health equity realized. The study also pointed out how women face unique-to-gender threats to their cardiovascular health at key life stages, such as during pregnancy and menopause. For example, the study cites findings from the Centers for Disease Control and Prevention that cardiac and coronary conditions are a leading cause of preventable maternal deaths (13 percent).
Two, the U.S. Food and Drug Administration issued draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the FDA receives about the patients who may potentially use a medical product under agency consideration.
The study and the draft guidance are meaningful. The grim findings on women’s cardiovascular health should be a call to action to enlist more women – of different ethnicities, ages, economic circumstances, and life stages – in clinical trials of medical devices that could benefit them. Medtech companies are making strides to do exactly that, but barriers remain. Identifying those barriers and breaking them down one by one are necessary to solve the dual problems of too little diversity in clinical trials and the serious health risks to women of undertreated and unresolved cardiovascular needs.
Medtech solutions exist to help clinicians treat the many women with cardiovascular conditions. Additional medtech solutions that are customized for women, and safe and effective in women, will emerge under positive conditions, including clinical trials enrolling more women, and more types of women. These achievements are within our grasp, thanks to the work of the American Heart Association, the FDA, medtech companies, and many other allies committed to better health for underrepresented and underserved people.
Want to get involved?
Comments on the FDA diversity plans in clinical trials draft guidance are due September 26, 2024. AdvaMed is planning to comment. We encourage comments from all perspectives.
Listen to American Heart Association CEO Nancy Brown’s conversation with Scott Whitaker on the Medtech POV podcast.
Deidre Washington, PhD, is AdvaMed’s director of health equity.