Participation of women in cardiovascular clinical trials is suboptimal and barriers need to be identified and addressed, according to an article published the Journal of the American College of Cardiology.
Noting that women and minority women are still underrepresented in most clinical cardiology trials, Leslie Cho, MD, from the Cleveland Clinic Heart, Vascular, Thoracic Institute, and colleagues identified barriers for low enrollment and retention from patient, clinician, research team, study design, and system perspectives.
The researchers identified eight barriers to optimal recruitment and retention of women. These barriers include differential care represented by lower rates of referral and less aggressive care for women with heart disease; for example, women with heart failure are less likely than men to be referred to a cardiologist and therefore may be less likely to receive care from clinicians recruiting for trials. Furthermore, older adults are disproportionately underrepresented in many trials, compounding the underrepresentation of women because disease prevalence is higher in women of older ages. Logistical barriers to research participation disproportionately affect women, including those barriers related to financial and caregiver requirements; limiting the number of onsite visits and increasing remote monitoring may increase participation. Other barriers include lack of diversity in clinical trial leadership; underrepresentation of minority women; special considerations for pregnant women; sex differences in cardiovascular disease; and study retention, a topic about which little is known.
“We owe it to our patients to increase representation of women and underrepresented minorities in cardiovascular disease trials,” Cho said in a statement.
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