On the health equity and diversity front, two important developments have been made.
For one, the American Heart Association published a landmark study concluding that women’s cardiovascular health may be less understood than we realize as we work toward health equity. The study also noted that women face gender-specific threats to their cardiovascular health during critical periods in their lives, such as pregnancy and menopause. For example, the study cited findings from the Centers for Disease Control and Prevention that heart and coronary artery disease is the leading cause (13%) of preventable maternal deaths.
Second, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plan to Improve Enrollment of Participants from Underrepresented Populations in Clinical Trials,” which aims to increase enrollment of participants from historically underrepresented populations in clinical trials and help improve the data the FDA receives about patients who may use drugs under FDA consideration.
This study and draft guidance are significant. The dire outcomes for women’s cardiovascular health should be a call to action to include more women – of different ethnicities, ages, economic statuses, and life stages – in clinical trials for medical devices that may benefit women. Medtech companies are making progress to do just that, but barriers remain. Identifying these barriers and breaking them down one by one will be necessary to solve the dual problem of too little diversity in clinical trials and the serious health risks that undertreated and unmet cardiovascular disease poses to women.
Medtech solutions exist to help clinicians treat the many women with cardiovascular disease. Under favorable circumstances, such as clinical trials that enroll more women and more types of women, additional medtech solutions that are customized for women and that are safe and effective for women will emerge. Thanks to the efforts of the American Heart Association, the FDA, medtech companies, and many other allies committed to improving the health of underrepresented and underserved populations, these outcomes are within reach.
Would you like to join us?
The deadline for comments on the FDA’s draft guidance on diversity planning in clinical trials is September 26, 2024. AdvaMed plans to comment and welcomes comments from all perspectives.
Listen to the conversation between American Heart Association CEO Nancy Brown and Scott Whitaker on the Medtech POV podcast.
Dr. Deidre Washington of AdvaMedDirector of Health Equity;
