Societies Push CV Trialists to Recruit More Women

Removing some of the seen and unseen barriers that keep women out of clinical trials—by taking steps to tackle their concerns head-on and empower them in decision-making—may go a long way toward improving female participants’ recruitment into cardiovascular research, according to a joint British Cardiovascular Societies’ consensus document.

The writing committee, headed by Vijay Kunadian, MBBS, MD (Newcastle University, Newcastle-upon-Tyne, England), was composed of collaborators from 22 organizations affiliated with the British Cardiovascular Society.

“For the first time we brought together all of the subspecialties involved in the care of female patients including patient representatives, nursing representatives, and primary care to ensure a collective effort,” Kunadian told TCTMD.

The committee assessed barriers that limit women’s participation across a spectrum of coronary artery disease, valvular disease, and heart failure. They then created sets of actionable points that they hope may enhance recruitment. Several of these points involve improving education for patients and families to help them in their decision-making around treatments and trials.

“Raising awareness that cardiovascular disease is the number one killer for women is so important, because many women and men are not aware of this,” Kunadian said. “They are also not aware that women are underrepresented in research.”

The consensus document was published June 1, 2025, in Heart.

Improving female trial participation is an ongoing battle. In one recent analysis, researchers found no lessening over the last two decades in the underrepresentation of women in cardiovascular clinical trials sponsored by the National Institutes of Health.

Talking to patients about the lack of women in CVD studies and why that’s a problem can help them open up to the idea of participating as well as understand they are adding value to the field, said Kunadian. Letting women know that treatments they’re being offered by their doctors are often based on what works for men, with less well-defined information on how therapies work for women, could be an effective strategy, the committee advises, because this reality is something patients simply may not have previously heard.

“It is also important to take time to explain everything to the female patient without rushing,” said Kunadian, who emphasized the importance of gaining trust.

This advice applies to conversations with the patient and her family and may involve making sure that patient education materials are female-facing and written to actively engage patients as partners in research and in their care process.

It’s also important to address cultural barriers uniquely associated with women from underserved communities. This could also be aided by a diverse research team that consists of male and female principal investigators.

Action Points From Different Perspectives

By collaborating with so many societies, the consensus statement provides action points created from the perspective of primary care, trainees, nurses, physiologists, and others. Patient representatives, for example, offered insight for actions such as giving women time to discuss trial participation with a family member, answers to frequently asked questions on an app or in written form, and access to a patient who has participated in a trial and is willing to talk about their experience. They also stressed the need to involve female patients in all the stages of research: from trial design to sitting on steering committees and helping disseminate the findings.

Ensuring that all aspects of the trial fit well with patients’ schedules may not be easy, but the committee notes that data suggest personal illness, transportation issues, and caregiving responsibilities are among the reasons women give for declining participation in certain studies.

Heart failure (HF) is an area that has historically much lower participation of women in trials versus the population incidence, including trials of HF with preserved ejection fraction. These trials, however, have tended to have higher-than-average rates of female enrollment compared with ACS trials.

Among the ways the committee suggests to increase the number of women in heart failure research are: improving the percentage of female trialists who are first or last authors; including those in leadership roles throughout the life cycle of the study; reconsidering and justifying exclusion criteria for those of childbearing age; individualizing approaches to contraception; and offering translation services for those with limited English.

“There are so many things that researchers can do,” Kunadian said. “Making the follow-up visits flexible to suit the female patient, providing child-care support and costs, [helping] the male members of the family to support the female patients, producing patient information sheets to ensure they are applicable to patients from different cultural backgrounds, and having patients with lived experience in the design of the study and in the trial team.”

The committee also suggests that some studies might consider virtual or home-based recruitment, engage specialist nursing teams into research recruitment, and offer information sessions and community outreach events in partnership with female health organizations and support groups within communities.

In an accompanying editorial, Gurleen Kaur, MD (Brigham and Women’s Hospital, Boston, MA), and Martha Gulati, MD (Cedars-Sinai Medical Center, Los Angeles, CA), say the perspectives offered in the consensus statement “challenge the status quo” and also highlight the philosophy “that research and the advancement of knowledge are not solely controlled by one domain but require team effort from the entire healthcare community.”

Kaur and Gulati add that without decisive and bold actions to implement the solutions proposed in the document, “we risk continuing to render women anonymous in cardiovascular research.”