Women remain underrepresented in cardiovascular clinical trials despite guidelines and legal requirements developed almost 30 years ago to ensure broader inclusivity, according to a report from the American College of Cardiology Cardiovascular Disease in Women Committee published today in the Journal of the American College of Cardiology. This lack of representation can limit availability of treatment data on the number one killer of women worldwide—cardiovascular disease.
“Historically, drug therapies for women were determined based on male data that was extrapolated to women,” said Leslie Cho, MD, FACC, lead author of the study, a member of the ACC Cardiovascular Disease in Women Committee, and director of the Women’s Cardiovascular Center and section head of preventive cardiology and cardiac rehabilitation at Cleveland Clinic. “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 committee issued this report to better understand the current barriers to enrollment and retention of women in clinical trials, as well as to offer novel strategies to help increase participation of women and, more specifically, underrepresented minority women, while also looking at women of childbearing age and pregnant women.
The authors present eight potential barriers to optimal enrollment of women and underrepresented minority women, including:
Recommendations for breaking down each barrier were presented in the report, as well.
“To address barriers to recruitment and retention of women in cardiovascular clinical
trials, 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,” Cho said. “We owe it to our patients to increase representation of women and underrepresented minorities in cardiovascular disease trials.”
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its 54,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.
The ACC’s family of JACC Journals rank among the top cardiovascular journals in the world for scientific impact. The flagship journal, the Journal of the American College of Cardiology (JACC) — and family of specialty journals consisting of JACC: Advances, JACC: Asia, JACC: Basic to Translational Science, JACC: CardioOncology, JACC: Cardiovascular Imaging, JACC: Cardiovascular Interventions, JACC: Case Reports, JACC: Clinical Electrophysiology and JACC: Heart Failure — pride themselves on publishing the top peer-reviewed research on all aspects of cardiovascular disease. Learn more at JACC.org.