Women, and especially minority women, remain under-represented in most clinical cardiology trials, despite guidelines and legal requirements put forward years ago to ensure broader inclusivity, according to a new report released by the American College of Cardiology (ACC) Cardiovascular Disease in Women Committee.
Women are particularly under-represented in trials of coronary artery disease, heart failure with reduced ejection fraction, and arrhythmia studies involving devices and procedures, the committee found.
Gender-specific data are essential to optimal cardiovascular care and "we need to make this a priority," committee member Leslie Cho, MD, director of the Women's Cardiovascular Center, Cleveland Clinic, told theheart.org | Medscape Cardiology.
"Increasing awareness about trials is critical for everyone. Also, having trial information be available to all patients, regardless of where they live, who they are, or where they get care is important," said Cho.
The report was published in the August 17 issue of the Journal of the American College of Cardiology.
Barriers and Solutions
In the report, the committee outlines barriers to enrolling women in CV clinical trials and offers strategies to help increase participation of women in these trials.
One key barrier is low referral rates to cardiologists and specialty programs for more aggressive care, leading to fewer women being treated by specialists who might be recruiting for clinical trials.
The committee recommends expanding awareness of ongoing trials to primary care providers and to community and safety-net hospitals, and to offer more locations of trial enrollment if possible.
Another barrier is "ageism," with older patients disproportionately under-represented in clinical trials overall, further compounding the under-representation of women in CV trials, as heart disease is significantly higher in older-age women.
The committee recommends expanding age criteria and limiting exclusion criteria that disproportionately affects the elderly. "It is critical that age and comorbidities be expanded in clinical trial inclusion criteria to reflect real-world patient population," they note.
A lack of awareness, trust, and logistical barriers is another obstacle to getting more women enrolled in CV clinical trials. Research has shown that women are more reluctant than men to consider trial participation.
Lack of Diversity in Leadership
The committee says efforts are needed to minimize logistical barriers for women, such as limiting the number of onsite visits, increasing remote monitoring when feasible, and extending on-site visit hours beyond regular business hours so people can attend before and after work.
Another barrier is the lack of diversity in clinical trial leadership, with men significantly more apt than women to lead clinical trials.
It is "critical to have representation of female leadership on trials. Trials with higher female leadership representation tend to have higher female patient enrollment," Cho told theheart.org | Medscape Cardiology.
The committee also highlights the low rates of minority representation in the majority of large CV trials.
They note, however, that clinical trials that have enrolled predominantly racial/ethnic minority groups have proven it is possible to have representation of these under-represented groups in clinical trial leadership, enrollment, and retention.
The committee also singles out pregnant women and women of child-bearing age, who are often excluded from clinical research because they are part of a "vulnerable" population, resulting in not only reduced numbers of eligible women, but a lack of data on how certain drugs affect pregnant patients.
"These rigid exclusion criteria were ultimately recognized as a major unintended contributor towards the general under-representation of women in drug development studies," the committee says.
Instead, they suggest pregnant women be considered a "scientifically complex" rather than "vulnerable" population in research trials, because as a group they are able to provide informed consent.
The committee also encourages drug studies on pregnant animals so that extrapolation of data can be available prior to including pregnant women in clinical trials.
"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 in a news release.
"We owe it to our patients to increase representation of women and under-represented minorities in cardiovascular disease trials," she added.
This research had no funding or support. Cho has received institutional research grants from Esperion, Novartis, AstraZeneca, and Amgen; and has been a consultant for Esperion, Amgen, and AstraZeneca. A complete list of disclosures for committee members is available in the original article.
J Am Coll Cardiol. 2021;78:737-751. Abstract
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Cite this: Women Still Under-represented in CVD Trials, Despite Requirements - Medscape - Aug 10, 2021.