Participation of women in clinical trials: not yet time to rest on our laurels

From the stories of workplace impropriety and sexual misconduct allegations, a movement emerged as a supportive platform for women to share their experiences in solidarity. This movement’s call for action has challenged all fields to examine institutionalized power dynamics and gender biases through a feminist lens. Advancing sex and gender considerations in the health care field can add to this growing movement. In the 1990s, the U.S. Food and Drug Agency’s (FDA’s) Office of Women’s Health established a specific program dedicated to support FDA research and development activities related to improving women’s health (1). Their mandate is to improve clinical study designs and procedures to better identify and evaluate possible sex differences in FDA-regulated products. As a response to various interest groups advocating for adequate representation of women in cardiovascular clinical trials, the FDA, as well as other agencies (i.e., National Institutes of Health [2], Canadian Institute of Health Research) established policies focused on greater participation of women in clinical trials to strengthen science and guarantee quality and generalizability of biomedical research, breaking the ceiling of health inequity. Reports of FDA drug approvals showed that women’s participation in clinical trials has progressively increased compared with reports from the 1990s that demonstrated a consistent underrepresentation of women (<20%) (3–5). Although women’s participation increased to 45% for new drugs approved between 2010 and 2012 (5), inclusion varies widely by indication and has been the lowest in cardiovascular trials (3–5).