Increasing Participation of Women in Cardiovascular Trials
Key result
Cardiology trials persistently underrepresent women and minority women, especially in CAD, HF, and arrhythmia studies.
Key Points
- Identify multidimensional barriers to enrolling and retaining women in cardiovascular trials and propose contemporary strategies to improve diverse trial recruitment.
- Narrative review of recent clinical cardiology trials across coronary artery disease, heart failure with reduced ejection fraction, and arrhythmia subspecialties.
- Qualitative analysis of trial enrollment obstacles spanning patient, clinician, research team, trial design, and systemic healthcare levels.
- Women, especially underrepresented minority women, remain persistently underenrolled in cardiovascular clinical trials despite regulatory mandates from federal agencies and professional societies.
- Enrollment disparities are most pronounced in trials evaluating coronary artery disease, heart failure with reduced ejection fraction, and procedural or device-based arrhythmia interventions.
Structured PICO
P
Population
Women and underrepresented minority women in clinical cardiology trials
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We know from numerous studies, too many to mention, that women have different pharmacokinetics compared to men and women tend to have more side effects. There are lots of instances where drug dosing is different between men and women, and yet these trials are 70% done in men and the recommendation is always carte blanche for both.”
“Historically, drug therapies for women were determined based on male data that was extrapolated to women. 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.”
“Unfortunately, the status quo of having the same centers enrolling the same population is going nowhere. Women are less likely to be referred. Minority women are even less likely to be referred.”
Implication
Women and underrepresented minority women remain significantly underrepresented in cardiovascular clinical trials, highlighting the need for systemic changes to improve recruitment and retention.
Abstract
Although some progress has been made in the last 3 decades to increase the number of women in clinical cardiology trials, review of recent cardiovascular literature demonstrates that women and underrepresented minority women are still underrepresented in most clinical cardiology trials. This is especially notable in trials of patients with coronary artery disease, heart failure with reduced ejection fraction, and arrhythmia studies, especially those involving devices and procedures. Despite the call from National Institutes of Health, Food and Drug Administration, Institute of Medicine, and various professional societies, the gap remains. This paper seeks to identify the barriers for low enrollment and retention from patient, clinician, research team, study design, and system perspectives, and offers recommendations to improve recruitment and retention in the current era.
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Cite This Study
Cho et al. (2021) conducted a review in Cardiovascular disease. Women and underrepresented minority women remain underrepresented in most clinical cardiology trials, particularly in studies of coronary artery disease, heart failure, and arrhythmias.