Establishing Excellence With the Women’s Health CARE Council

Women’s health remains one of the most overlooked and underrepresented areas in clinical research, often leading to gaps in treatment and understanding. Similar to obesity research, disorders relating to reproductive health include symptoms that are highly stigmatized and patients can be reluctant to seek treatment or join clinical trials. This is why Velocity set up a dedicated Women’s Health Council to Accelerate Research Excellence (CARE Council).

Velocity’s CARE Councils are expert-led groups designed to ensure consistency and efficiency in areas of significant therapeutic need. They bring together cross-functional teams to collaboratively shape study design, review emerging trends, and refine best practices across our 80+ global sites.

Velocity’s Women’s Health CARE Council is led by renowned OB/GYNs and women’s health specialists, and has supported more than 600 women’s health trials across Velocity’s global network. The council works to ensure Velocity sites are fully prepared to support and retain female participants in clinical trials, offering Sponsors and CROs access to a diverse patient population and support to refine and optimize trial protocols.

Closing the Gender Gap

Women remain underrepresented in clinical trials, accounting for around one-third of participants in Phase 1 trials. This is despite a push for greater inclusivity and an industry-wide effort to shake off the fear of admitting women of childbearing age to join early-stage studies, even when there is little or no chance of pregnancy.

“Our research shows that women are broadly motivated by the same factors as men,” explains Margaret Rhee, MD, Women’s Health CARE Council leader. “Two in five enroll to contribute to scientific advancement – particularly as it relates to women’s health – and this motivation increases among those with prior trial experience.” Many plan to participate again in 2025, meaning there is potentially a large patient population for Sponsors to tap into.

Addressing Gaps in Recruitment and Retention

Once engaged in clinical trials, women are less likely than men to continue beyond phase one and two and into Phase three studies — often due to the increased time commitment and logistical demands. Addressing this requires an approach that prioritizes patient experience, a core focus for CARE councils.

“We know that women face different barriers to staying in trials. Whether it’s caregiving responsibilities, travel burdens, or feeling unsupported, we need to actively work to remove those barriers,” says Sara Friedman, MD, Women’s Health CARE Council leader.

Technology helps support this. VISION, Velocity’s proprietary AI-powered technology platform, accelerates the prescreening process by consolidating multiple surveys, reducing redundancy, and automatically identifying eligible participants. Patients who express interest in a trial receive timely updates and personalized study recommendations in-app. By keeping communication consistent and ensuring women can easily find and enroll in studies that fit their needs, VISION helps sustain engagement and reduce drop-off rates.

“Participants have a strong interest in enrolling, but without clear, ongoing communication, we risk losing them before the trial even begins,” says William Beacham, MD, Women’s Health CARE Council leader. “VISION ensures that recruitment is efficient and patient-centered, making it easier for patients to connect with relevant studies.”

Patient Comfort in Clinical Trials

According to a recent patient survey conducted by Velocity in January 2025, around a quarter of women who’ve already completed at least one study have expressed significant interest in enrolling in women’s health-related trials in 2025. Nearly a third (30%) are interested in diabetes and obesity trials, a figure broadly in line with male interest in those studies (36%).

Psychological safety — ensuring patients feel respected and valued — plays a crucial role in supporting recruitment and retention in these high-demand therapeutic areas. The Women’s Health and Diabetes and Obesity CARE Councils work together to ensure that every Velocity site has staff trained to facilitate neutral and supportive communication and that sites have the appropriate equipment to meet patient needs without discomfort or stigma.

“It’s not just about recruitment numbers, but ensuring patients stay engaged and complete the trial. We’re continuously refining our approach to ensure participants are engaged and feel supported at every stage,” says Dr. Rhee.

Driving Progress in Women’s Health Research

Women now make up 58% of trial participants across all phases in Velocity-run clinical trials. The Women’s Health CARE Council plays a significant role in driving that; eliminating barriers to participation, improving engagement, and ensuring site readiness.

For CROs and Sponsors looking to optimize their next women’s health trial, the Women’s Health CARE Council provides a network of ready-to-enroll patients and experienced investigators with a proven track record of execution.

To learn more about how our CARE councils can support your next study, connect with Liz Wilson or email lwilson3@velocityclinical.com.

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