A new study has found that women remain underrepresented in cardiovascular drug and device clinical trials despite guidelines and legal requirements developed almost 30 years ago to ensure broader inclusivity.
“Historically, drug therapies for women were determined based on male data that was extrapolated to women,” explains Leslie Cho, lead author of the paper. “However, research has shown that women respond differently than men and may even be harmed or experience side effects from some drugs when taken at the same dosage as men. Sex-specific data is essential to optimal care.”
The authors conclude that moving forward, to address barriers to recruitment and retention of women in cardiovascular clinical trials there needs to be “a comprehensive and targeted approach that involves partnership with all stakeholders – patients, referring clinicians, research teams (investigators and coordinators), health care systems, the FDA, payers, sponsors, professional and community organizations – is essential.”
Leslie Cho is director of the Cleveland Clinic’s Women’s Cardiovascular Center. She is also section head, Preventive Cardiology and Rehabilitation, and chief quality officer in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic. Dr. Cho received her undergraduate degree in interdisciplinary studies from the University of California, Los Angeles. She received her medical degree from the University of Chicago Pritzker School of Medicine. Earlier in her career, she taught at Loyola University in Chicago.
The full study, “Increasing Participation of Women in Cardiovascular Trials,” was published in the American Journal of Cardiology. It may be accessed here.