Cardiovascular disease is a leading cause of death for women, yet they are significantly underrepresented in clinical trials for common heart conditions. This concerning issue was highlighted by researchers at the Smidt Heart Institute at Cedars-Sinai during a presentation at the ESC Congress 2025 in Madrid.
Dr. Martha Gulati, the director of Preventive Cardiology at the Smidt Heart Institute and senior author of the study, emphasized the importance of addressing this disparity. She pointed out that the numbers clearly indicate the lack of female participation in cardiovascular clinical trials and urged researchers to design studies that better reflect the real-world population.
The research, which was presented at the European Society of Cardiology Congress and published in JAMA Network Open, analyzed data from over 1,000 cardiovascular clinical trials conducted between 2017 and 2023. The study revealed that women made up only 41% of the participants, with certain conditions like coronary heart disease, acute coronary syndrome, and stroke having particularly low female representation.
To assess the discrepancy, the researchers used a metric called the participation-to-prevalence ratio (PPR) to determine if the percentage of women in a trial accurately reflected the prevalence of the condition among women. The findings showed that younger women were more likely to participate in trials compared to older women, and lifestyle intervention studies attracted more female participants than procedure-focused trials.
Dr. Gulati suggested that trials should continue enrolling participants until they achieve a more balanced representation of women with the condition being studied. Additionally, the authors recommended improving outreach efforts to encourage more female patients to participate in clinical research.
Dr. Susan Cheng, the Erika J. Glazer Chair in Women’s Cardiovascular Health and Population Science at the Smidt Heart Institute, emphasized the need to address the existing gaps in cardiovascular research. She highlighted the importance of ensuring that research findings can be applied to women, who make up more than half of the global population.
In conclusion, the study underscores the critical need for increased female participation in cardiovascular clinical trials to improve the generalizability of research findings and enhance the quality of care for all patients. By addressing the gender disparity in clinical research, we can advance our understanding of heart conditions and provide more effective treatments for women worldwide.
