Clinical trials are the backbone of modern medicine, shaping how diseases are diagnosed, treated, and prevented. Yet, despite making up half the population, women’s participation in clinical trials is significantly low. This disparity leaves gaps in understanding women’s health concerns and how many conditions impact critical questions unanswered, particularly for conditions that disproportionately or uniquely affect women.
New research, including recent insights from UPMC Enterprises, explains what is happening: women are not absent from clinical trials because they lack interest, but because systemic barriers continue to limit their participation. At the same time, many of the very complicated conditions that most need research — like endometriosis and polycystic ovary syndrome (PCOS) — remain underfunded and poorly understood.
Many women’s health issues are not being studied, and even when women are aware that clinical trials exist, awareness does not automatically translate into participation. Aside from concerns about trial safety, women may not have the time to commit to the trial. Women who may be interested are now hesitant to enroll.
This hesitation is especially significant when it comes to under-researched conditions. Take endometriosis, for example, which occurs when the uterine lining grows outside of the uterus, leading to severe pain and, oftentimes, infertility and scar tissue. This is a disease that affects millions but can take years to diagnose.
Without robust clinical trials, patients are left with limited treatment options and few evidence-based solutions. The same is true for PCOS, which can cause hormonal imbalances, insulin resistance, and infertility. Most treatments focused on managing symptoms rather than actually curing the condition or finding its cause.
Fear of side effects and unknown outcomes continues to deter participation. These concerns are amplified by a long history of excluding women, especially those who are pregnant. Studying pregnant women is still taboo even though it may be necessary.
For women dealing with complex or poorly understood conditions, the stakes feel even higher. Someone living with fibromyalgia, for instance, may already feel dismissed by the health care system. The idea of entering a clinical trial, where testing is still underway, can feel like an added risk rather than an opportunity.
Healthcare providers are among the most trusted sources of information about clinical trials, but they may be too overwhelmed by their workloads to keep up with trials. Without proactive provider engagement, eligible patients may never even learn about trials that could benefit them.
Trust also plays a central role. Women are more likely to participate when trials are recommended by a provider they trust, underscoring the importance of strong patient-provider relationships.
Logistical challenges remain a major obstacle for increasing women’s participation in clinical trials. Clinical trials often require frequent in-person visits, travel to specialized centers, and rigid schedules. For women balancing careers, caregiving, and household responsibilities, participation can feel unrealistic.
These barriers are particularly problematic for conditions like uterine fibroids, which disproportionately affect women during their working and caregiving years. Similarly, women navigating menopause may struggle to find trials that accommodate their daily realities, even though menopause affects every woman and remains surprisingly under-researched.
One of the most persistent issues is the lack of invitation. While many women express openness to participating in clinical research, only a small percentage are ever asked to do so.
This is particularly problematic for conditions where research is already limited. Without intentional recruitment strategies, these patients remain excluded from research that could directly improve their care.
Similarly, women with autoimmune conditions (who make up the majority of patients with diseases like lupus) are often underrepresented in trials designed to understand those very illnesses.
Closing these gaps will require more than awareness campaigns. Doing so requires an overhaul of how clinical trials are conducted.
Patient-centered approaches are key. These include:
Technology can also help identify eligible participants and connect them to trials more efficiently. But innovation alone isn’t enough. Trial design must reflect the realities of women’s lives.
Just as importantly, researchers must prioritize conditions that have historically been overlooked. Expanding trials for diseases like endometriosis, fibroids, and menopause-related health issues is critical to closing long-standing knowledge gaps.
Improving women’s participation in clinical trials is not just about equity—it is about better science. When women are excluded, the data is incomplete, and the care that follows is less effective.
The path forward requires coordinated action:
Ultimately, addressing barriers to participation and closing research gaps must go hand in hand, as the same systems that restrict women’s access to clinical trials have also allowed critical health issues to remain understudied. Fixing one without the other is not enough. If clinical trials are truly meant to serve everyone, they must reflect everyone.
Achieving this will require rethinking how trials are designed and offered, building trust through established care providers, and making participation more compatible with the realities of women’s busy lives.
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