The under-representation of women in cardiovascular clinical trials: State-of-the-art review and ethical considerations.

Abstract

This review describes and evaluates the representation of women in cardiovascular randomized controlled trials (RCT), it reports significant under-representation of women in clinical trials both as participants and researchers and discusses the ethical implications of under-representation. The under-representation of women as participants in cardiovascular RCTs is evident in trials investigating cardiovascular drugs, acute coronary syndrome, heart failure and interventional procedures and devices. Under-representation of women is also evident in the authorship of cardiovascular clinical trials and in trial leadership roles, and under-representation of women as trial investigators is independently associated with under- recruitment of women as trial participants. A notable lack of RCTs investigating conditions that disproportionately affect women is also evident, this triad of underrepresentation for women as participants, and investigators, and the lack of RCTs into conditions predominantly experienced by women, all contribute to the gender gap in cardiovascular outcomes. Better representation of women in clinical trials, in trial leadership and authorship is a key factor to address to equity, distributive justice and improve outcomes for women with cardiovascular disease.