- Women were underrepresented at under 20% of subjects in clinical trials in the 1990s.
- The Food and Drug Administration (FDA)’s Office of Women’s Health (OWH) was formed in 1994 with a mission to ensure adequate involvement of women in clinical trials and to identify specific requirements and challenges for women’s health.
- Cardiovascular disease is the leading cause of death in the United States, although women experience the disease differently than men.
- Part of the efforts of OWH include supporting clinical trials involving women with cardiovascular disease and its treatments or procedures.
- The OWH supported studies have led to 1) increased understanding of cardiovascular disease in women; and 2) guidances regarding drug and device clinical trial design.
- Although participation of women in clinical trials increased to 45% between 2010 and 2012, women were least represented in cardiovascular clinical trials.
- There were also concerns that there could be gender differences in response to marketed products.
Based upon analysis of 36 cardiovascular studies conducted between 2005 and 2015, the FDA published an article entitled “Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs” in the Journal of the American College of Cardiology. Findings include:
- Women were adequately represented in trials for hypertension and atrial fibrillation, over-represented for pulmonary arterial hypertension, and under-represented in heart failure, coronary artery disease, and acute coronary syndrome.
- There were only minor differences in cardiovascular drug safety or efficacy for women compared to men.
Although women are better represented in cardiovascular clinical trials in the last decade compared with numbers from the 1990s, stakeholders continue to face challenges enrolling adequate numbers of women in certain cardiovascular studies. The evolution of the FDA’s guidance on inclusion of women in clinical trials supports advancing knowledge on the differences of drug and device safety and efficacy in women.
-The Clinical Pathways Team
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