hile medicine has made extraordinary advances over the last several decades, a gaping hole in research for conditions that affect women uniquely, differently, or disproportionately compared to men continues to exist. As a result, women are suffering from delayed diagnoses, ineffective treatments, and poor health outcomes. We lack critical insights into how female physiology impacts disease risk, symptom expression, and treatment response across sex-specific and common conditions. Women are living in worse health despite living longer than men on average globally, and this reality is negatively impacting the global economy. Women’s health is long overdue for a transformation.

Despite comprising 50% of the global population, women continue to be excluded from critical health research and innovation. Only 7% of biopharma R&D is invested in conditions that exclusively affect women, and less than 1% of that is spent on diseases beyond cancer. Women also remain underrepresented in clinical trials for common diseases that affect both men and women, limiting our ability to understand sex-specific differences in treatment efficacy and safety. In addition, of the few medications that are approved and prescribed, only 5% have been adequately monitored and labeled for safety during pregnancy or lactation.

This underinvestment in women’s health influences how conditions are diagnosed, how treatments are developed and prescribed, and how care is delivered. We can’t afford to ignore these statistics any longer.

The Urgent Need to Transform Women’s Health Research

Experts in this field have identified a central truth: Innovation in women’s health requires a fundamental shift in how we think about, study, and deliver care for women. New policies are needed to rewrite the script and change the trajectory for the future of global health. That includes reshaping clinical trials, medical curricula, study protocols, and care guidelines with sex-specific needs in mind.

It’s important to remember that these aren’t just numbers. Women’s lives are at stake. Policies that promote more robust science will contribute to improved productivity, longevity, and quality of life for women worldwide.

Healthcare stakeholders (see below) came together at DIA’s 2025 Global Annual Meeting to identify policy changes that will advance women’s health research, improve health outcomes for women around the world, and unlock up to $1 trillion in global GDP by 2040.

Barriers to Progress

Navigating a new landscape in women’s health takes persistence, collaboration, and time. Despite growing awareness of the disparities in women’s health, systemic barriers continue to stall meaningful progress. According to the White Paper Prescription for Change, barriers include:

• A stalled innovation pipeline. While women-specific conditions such as endometriosis, menopause, and maternal health affect millions, they remain dramatically underfunded and understudied. This “drought” in innovation leaves women with outdated, ineffective, or even harmful treatments.
• Lack of inclusion in clinical trials. Women remain significantly underrepresented in clinical research, especially pregnant and lactating women, post-menopausal women, or women of color. The result is a major lack of critical safety, efficacy, and dosing data for half the population.
• Missing and incomplete data. Even when women are included, sex-disaggregated data are rarely reported, obscuring how interventions may work differently in women’s bodies. Furthermore, most global data systems fail to account for how sex intersects with race, age, and socioeconomic status. This has led to generalizations that overlook high-risk populations and perpetuate inequities.
• Male-centric research design. Medical research has long used the male body as the default. This one-size-fits-all approach not only limits our scientific understanding but also harms women by leading to potentially inappropriate or ineffective treatments.
• Lack of sex-specific insights. Without sufficient sex-specific research and data, we lack the insights we need to understand how conditions manifest, progress, and respond to treatment in women. This is especially relevant with regards to pharmacology, where side effects and drug interactions may differ in women due to hormonal, metabolic, and immune system differences.

Key Policy Recommendations and Stakeholder Insights

While many barriers exist, they can also be reframed as opportunities to pave the way for better outcomes in the future:

1. Innovation.

At the heart of Prescription for Change is a clear call for innovation in women’s health. To achieve this, we need physicians to leave behind outdated frameworks and stop being afraid of including women in clinical research.

A new standard of care begins with mandatory women’s health education in medical training, integrating topics like menopause, maternal health, and sex-specific disease presentation. We need intake protocols to evolve to ask the right questions, recognize whether there are any fundamental differences between men and women regarding disease mechanism and manifestation, encourage open communication, and recognize the nuanced experiences that women bring to the clinical setting.

To achieve this, regulatory and financial incentives can catalyze the innovation needed to meet these evolving demands. Priority review vouchers, tax credits, matched public–private investments, and revised pricing and reimbursement strategies can help close persistent funding gaps, specifically in the US. These tools create meaningful incentives for stakeholders to prioritize women’s health. By encouraging research that reflects the lived realities of women, we can unlock the full potential of science to deliver more equitable, high-impact care.

2. Inclusion

At the root of poor outcomes is a lack of inclusion of women in clinical trials across all phases, especially women of color, post-menopausal women, and pregnant or lactating women.

A maternal investigation framework, similar to investigation plans developed for pediatrics, aims to build the foundation for the responsible inclusion of these historically understudied groups—particularly pregnant and lactating women—by identifying the unmet medical needs in this population and setting research expectations and patient safety guardrails. Targeted incentives and updated regulatory requirements can encourage researchers and sponsors to generate more representative data. Equally important is training for regulators, researchers, and trial staff on how to design inclusive studies and why it matters—because better data leads to better outcomes.

Global alignment, education reform, and inclusive policy incentives are essential to bridge geopolitical and social determinants of health, move beyond awareness, and deliver actual outcomes. Marketing messages tailored to different sectors, from pharma to policymakers, and championed by influential voices in healthcare could help drive real progress in this area.

3. Data

Improving women’s health requires data that is standardized, disaggregated by sex, and reflective of the physiological differences between men and women across the lifespan. ICH-level guidance, maternal and women’s investigational plans, and required sex- and gender-based assessments in research funding can help close data gaps and ensure accurate, inclusive insights.

Education and policy are also essential. Incorporating sex-based training into curricula and revising inclusion criteria in early-phase trials will strengthen evidence and dosing accuracy. Public-private partnerships can further support analysis and global data sharing to enhance insights and representation.

4. Design

Clinical trials must be intentionally designed with women in mind, accounting for biological differences and ensuring diverse participation. This includes engaging patients early, revising inclusion criteria, and integrating trials into routine care to reduce the impact of typical barriers to participating in research, such as childcare and transportation.

Reframing trial development as a design challenge can incentivize innovation. Competitions and grant programs can spotlight protocols that prioritize equity and scientific rigor, moving us from outdated frameworks to more inclusive, effective research.

5. Insights

We must find new ways to deepen and disseminate insights on sex-specific differences across the research, clinical, and regulatory ecosystems. Updating clinical guidelines, product labels, and patient information to reflect these differences is a critical step toward ensuring that treatments are safe and effective for all. The widespread adoption of the SAGER (Sex and Gender Equity in Research) guidelines in scientific publishing offers a fast, scalable way to standardize transparent reporting of sex-disaggregated data—a quick win that can catalyze broader change.

Beyond publishing standards, a more holistic approach to knowledge translation is needed. Embedding sex-based insights into clinical decision-making tools, medical education, and continuing professional development can close the gap between evidence and practice. Additionally, integrating patient-reported outcomes and lived experiences into data analysis will offer a more nuanced understanding of how disease and treatment manifest in women’s lives.

Charting the Way Forward

Solving these challenges requires more than incremental progress. It demands structural transformation. That means funding innovation that is intentionally centered on women’s health needs, reimagining clinical trial protocols to be inclusive by design, and expanding data sets to capture real-world, representative experiences. It also requires us to recognize that women are not a “special” subpopulation; they are a central pillar of global health, worthy of comprehensive sex-specific research, inclusive and compassionate care, and sustained interest and investment.

Sex-specific research, inclusive clinical trial design, and equitable innovation are critical yet often neglected pillars of global healthcare. The urgent need to reform how conditions that uniquely, differently, or disproportionately affect women are studied and treated points to persistent underinvestment, exclusion from clinical trials, and male-centric research design as key barriers.

Experts at the DIA roundtable identified five strategic imperatives in response:

1. fostering innovation;
2. increasing inclusion;
3. improving data standards;
4. redesigning clinical trials with women in mind; and
5. deepening insights through updated guidelines and inclusive reporting.

These reveal a growing consensus that transforming women’s health requires not incremental improvement, but systemic change supported by aligned policy, regulatory incentives, and a commitment to equity.