Are We Any WISER Yet? Progress and Contemporary Need for Smart Trials to Include Women in Coronary Artery Disease Trials

Despite calls to ensure proportionate representation of both sexes in biomedical research, women continue to be underrepresented in cardiovascular disease (CVD) clinical trials. A comprehensive analysis of seven large suspected ischemic heart disease/coronary artery disease (IHD/CAD) clinical trials (PROMISE, ISCHEMIA, CIAO-ISCHEMIA, ORBITA, FAME, FAME 2 and COURAGE trial) provides understanding of contributions to barriers to enrollment of women and leads to strategies to address these barriers. Specifically, in the seven trials, enrollment of women did not exceed 27%, while numerous barriers are evident. Proposed strategies to improve women´s inclusion in clinical trials, include adding reproductive stage/estrogen status, attention to study design inclusion/exclusion criteria using female thresholds, consideration of diagnostic and intervention study design to be inclusive, increasing women and minorities in leadership positions, including sex as a biological variable (SABV) in study design and statistical analysis, and addressing social and race/ethnicity barriers. Dedicated action to actualizing these steps are needed at this time to developing diagnostic and therapeutic strategies resulting in better care and improved outcomes for CVD in women.