FEMALE participation in cardiovascular clinical trials remains below desirable levels for several major disease groups, with women making up just 41 percent of total enrollees between 2017 and 2023. New research highlights gaps particularly in studies on arrhythmia, coronary heart disease, and heart failure and calls for immediate efforts to improve inclusion.
In a systematic review, researchers analysed data from 1,079 cardiovascular trials registered on ClinicalTrials.gov over a six-year period, with nearly 1.4 million participants. The study found women accounted for 41 percent overall, but participation varied widely by disease type. The female-to-male ratio was lowest for trials on arrhythmia (median 0.5), coronary heart disease (median 0.39), acute coronary syndrome (median 0.32), and heart failure (median 0.51). Conversely, trials on obesity and pulmonary hypertension overrepresented women, with median ratios of 1.44 and 2.86 respectively. Lifestyle-focused interventions included more women than drug trials, and geographic factors also influenced participation. Critically, the participation to prevalence ratio (PPR) was below expected for coronary heart disease, acute coronary syndrome, and stroke, suggesting many trials fall short of reflecting the real-world disease burden among women.
Cardiovascular disease is the leading cause of death worldwide for both men and women, yet women continue to be underrepresented in vital research that shapes clinical care. This lack of representation can limit how well treatments address their needs, especially given higher rates of complications and mortality for heart conditions among women. The review supports ongoing advocacy to close these divides and improve the quality of research that shapes heart health for everyone.
Reference
Rivera FB et al. Participation of women in cardiovascular trials from 2017 to 2023: a systematic review. JAMA Netw Open. 2025;8(8):e2529104.
