A new Cedars-Sinai-led study reports women are underrepresented in clinical trials involving coronary heart disease, acute coronary syndrome and stroke. Image by Getty.
Sept. 2, 2025 — Although cardiovascular disease is a leading cause of death for women, they remain underrepresented in clinical trials for common heart conditions. These findings, by investigators in the Smidt Heart Institute at Cedars-Sinai, were presented at the 2025 European Society of Cardiology Congress in Madrid.
“Numbers don’t lie,” said Martha Gulati, MD, director of Preventive Cardiology in the Smidt Heart Institute and senior author of the paper. “We hope that keeping track of male-to-female participant ratios will motivate researchers to design trials that reflect the real-world population.”
Gulati presented the findings in an oral abstract at the European Society of Cardiology Congress. The results were simultaneously published in JAMA Network Open.
Gulati and colleagues reviewed data from 1,079 cardiovascular clinical trials registered on ClinicalTrials.gov from 2017 to 2023. Women accounted for 41% of the study participants. Investigators found the proportion of women included in clinical trials for certain conditions was much lower than the proportion of women who have these conditions.
The team applied a ratio called the participation-to-prevalence ratio (PPR) to capture whether the percentage of women in a clinical trial reflected how common the condition is among women. The participation-to-prevalence ratios for women were lowest for trials of coronary heart disease, acute coronary syndrome and stroke. Research on obesity and pulmonary hypertension had much higher female participation.
Investigators also found that younger women, ages 19 to 55, were more likely to participate in clinical trials than women 61 or older, and that women tended to enroll in trials studying lifestyle interventions and not trials studying procedures.
“Some studies might stop enrolling once they reach a certain number of people,” Gulati said. “It would be more equitable to continue enrolling until the number of women in the study reflects the proportion of women with that condition.”
The authors also recommend researchers improve outreach efforts to female patients.
“Although we’ve made progress, critical gaps persist,” said study co-author Susan Cheng, MD, MPH, the Erika J. Glazer Chair in Women’s Cardiovascular Health and Population Science in the Smidt Heart Institute. “It’s important to ensure that what we learn from research can be applied to women, who represent more than half of the world’s population.”
For more information, please visit www.cedars-sinai.org.
Frederick Berro Rivera, MD, is first author of the study. Other authors include John Vincent Magalong, MD; Nathan Ross B. Bantayan, BSc; Nicole Tesoro, MD; Mark Jason Milan, MD; Vikramjit Purewal, DO; Polyn Luz S. Pine, MD, MBA; Chieh-Mei Tsai, MD; Ann Marie Navar, MD, PhD; Sharon L. Mulvagh, MD; James Januzzi, MD; C. Michael Gibson, MD; Anuradha Lala-Trindade, MD; Kyla Lara-Breitinger, MD; and Mayra Guerrero, MD.
This work was supported by contracts from the National Heart, Lung, and Blood Institutes, General Clinical Research Center, National Center for Advancing Translational Sciences, Department of Defense, Gustavus and Louis Pfeiffer Research Foundation, Women’s Guild of Cedars-Sinai Medical Center, Ladies Hospital Aid Society of Western Pennsylvania, QMED, Edythe L. Broad and the Constance Austin Women’s Heart Research Fellowships (Cedars-Sinai Medical Center), Barbra Streisand Women’s Cardiovascular Research and Education Program (Cedars-Sinai Medical Center), Society for Women’s Health Research, Linda Joy Pollin Women’s Heart Health Program, Erika Glazer Women’s Heart Health Project, Adelson Family Foundation (Cedars-Sinai Medical Center), Robert A. Winn Diversity in Clinical Trials Career Development Award, and the Anita Dann Friedman Endowment in Women’s Cardiovascular Medicine & Research.
August 29, 2025 
