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From insulin to immunotherapies, clinical trials have powered some of the most important medical breakthroughs of our time. But for all the progress we’ve made, one glaring issue continues to undermine clinical research: the persistent under-representation of women in trials.
Historically, women have been treated as "little men" in medicine — an oversimplification that has had significant consequences. From diagnostic criteria to dosing guidelines, much of modern medicine is built on data skewed toward male physiology. Women’s unique hormonal, metabolic, and physiological differences are often overlooked, leading to frequent misdiagnoses, inappropriate dosing, and unmet therapeutic needs.
This imbalance is especially serious when considering critical life stages such as menstruation, pregnancy, and menopause, as well as conditions including cardiovascular disease, autoimmune disorders, and neurodevelopmental conditions. For example, a study in 2020 found that fewer than 1% of US clinical trials included pregnant participants, leaving clinicians with little evidence on how to safely treat this group. In the absence of robust data, healthcare providers are often forced to make educated guesses — a precarious approach to patient care.
The exclusion of women from clinical trials stems from a mix of caution and convenience. In the 1960s, the thalidomide crisis prompted regulatory agencies to bar women of childbearing potential from participating in research to protect against birth defects.
While well-intentioned, this decision effectively sidelined women from trials for decades. Although policies began shifting in the late 1990s to encourage greater inclusion, many gaps remain. Key areas like endometriosis and menopause remain woefully understudied despite their profound impact on women’s quality of life. Endometriosis, for example, affects up to 10% of women of reproductive age, causing chronic pain and infertility, yet, it still takes an average of eight years to diagnose. Meanwhile, menopause, which can span up to one-third of a woman’s life, brings symptoms such as brain fog, hot flashes, and anxiety, yet receives minimal research funding relative to its impact.
Autoimmune disorders, which affect women at significantly higher rates than men, also exemplify this disparity. These conditions not only increase the risk of cardiovascular disease and metabolic complications, but are often influenced by hormonal changes throughout life. Still, clinical trials rarely stratify female participants by life stage or hormonal status, limiting the relevance and reliability of the data.
The good news? Solutions exist. Here are five steps we can take to close the gender gap in research:
1. Design trials with women in mind
Rather than treating women as a "special” population, researchers should make sex-based stratification standard in trial design. Collecting data on hormonal status, menstrual cycles, contraceptive use, and menopausal stage can yield richer insights. Trials should also include female-specific endpoints and use validated tools that capture symptoms unique to women.
2. Adopt digital tools and FemTech
Wearables and apps have transformed how women monitor their health. FemTech solutions can track hormonal cycles, monitor cardiovascular metrics, and collect real-time data that reflects female physiology. While this integration is still in its early stages, it holds tremendous potential for precision medicine and inclusive study designs.
3. Expand decentralised trial models
Decentralised clinical trials allow individuals to participate from the comfort of their homes, minimising the need for travel or time off. Providers can also educate patients about clinical research and refer them to relevant studies – but only if they themselves are equipped with the knowledge and resources to do so
4. Change the incentive structures
Regulatory bodies such as the FDA and EMA should require sex-disaggregated data, work, and childcare arrangements, which are common obstacles that prevent women from enrolling in traditional studies. These models also improve geographic and socioeconomic diversity, making it easier to reach populations that have historically been excluded from research. Decentralised models aren’t just convenient; they are essential for inclusion.
5. Diversify leadership and improve education
More women in leadership positions across research institutions, clinical research organisations, and regulatory agencies means more attention to the questions that matter to women. Primary care providers can also play a role by educating patients to diversity in recruitment through financial rewards or expedited reviews. Representation must be required, analysed, and reported as a central component of trial success.
A truly inclusive clinical trial ecosystem would incorporate women's health needs at every stage from hypothesis generation to post-market surveillance. It would stratify data by sex and life stage, utilise genomics for tailored therapies, and ensure the research team reflects the studied population. It would also respect the voluntary nature of trial participation while removing structural barriers like inflexible scheduling, childcare responsibilities, and transportation limitations.
Such transformation is within reach. Innovations in artificial intelligence, digital health, and decentralised models have made inclusive trials not just possible, but practical. With deliberate effort, we can ensure that women are no longer an afterthought in medical research, but a central consideration — because, when clinical trials reflect the diversity of the real world, everyone benefits.
This article was originally published on pharmaphorum, July 15, 2025.
Understanding the complexities of women's health is just the beginning. If you're looking to advance women's healthcare through clinical research, Lindus Health is your dedicated partner. Our full-stack service offering ensures your clinical trials are managed efficiently from start to finish, with an all-in-one platform tailored to your needs. Book a meeting with our team today to explore how we can support your next study and contribute to the future of women's health.
