Why more must be done to close the women’s health research gap

The information that shapes medicine today – and what’s considered effective treatment for conditions affecting women – is predominantly based on male biology. And yet, globally, more women than men receive clinical care.

This is the paradox at the heart of women’s health research: despite higher healthcare usage, women’s unique health needs remain under-researched and under-addressed. This disconnect contributes to a significant physical and social burden that many women face during their lifetimes.

Despite living an average of five years longer than men, women spend 25% more of their lives in poor health or with some degree of disability.

Persistent gaps in women’s health research and innovation undermine progress towards global resilience. Closing this gap could yield seven additional healthy days per woman yearly – and unlock up to $1 trillion in annual global gross domestic product by 2040.

Economics aside, the real victory in closing the women’s health gap would be lasting improvements in health and well-being for women across the globe. The need for change is undeniable and urgent.

The Global Alliance for Women’s Health, in collaboration with Kearney and the Gates Foundation, has launched a white paper advocating for policy changes to advance innovation and inclusivity in women’s health, including more representative clinical research.

Women’s bodies fundamentally differ from men’s, with unique organs, genes, hormones and other physiological processes. These differences cause women to experience many medical conditions differently and disproportionately compared to men. Yet sex-specific research is lacking.

The data is unequivocal: only 7% of healthcare research focuses on conditions exclusively affecting women. Though progress has been made over the past 30 years and representation of women in clinical trials has improved, critical gaps remain.

This is particularly true concerning early-phase clinical trials, which can lead to inaccurate dosing and compromises in safety and efficacy, and in important therapeutic areas such as cardiology and oncology.

Pregnant and breastfeeding women face even greater risks. Today, only 5% of available medications have been adequately tested, monitored and labelled with safety information for use during pregnancy and breastfeeding.

As a result, women with chronic conditions are often forced to either take unapproved medications during pregnancy or discontinue treatment, neither of which is ideal.

Furthermore, sex-disaggregated data are frequently missing from published trials. For example, only 7% of migraine trials and 17% of ischaemic heart disease trials publish sex-specific results. This lack of data undermines the ability to design effective, targeted interventions that reflect how women uniquely experience disease.

The gender gap in health research has far-reaching implications, influencing diagnosis, treatment and ultimately health outcomes for women across the globe.

From endometriosis and menopause to cardiovascular disease, autoimmune disorders and dementia, the health challenges women face are broader and more complex than clinical research currently acknowledges.

Under-research leads to poor understanding and treatment, sometimes putting women at risk. For example, research shows that medicines are 3.5 times more likely to be withdrawn for safety risks in women.

Since 2000, adverse events in the United States have been reported 52% more frequently in women than men. Research shows that medicines are three and a half times more likely to be withdrawn for safety risks in women.

The Alliance’s new white paper charts a strategic path to closing the women’s health research gap, with practical policy recommendations that can drive coordinated action. The paper, Prescription for Change: Policy Recommendations for Women’s Health Research, recommends:

Regulatory changes, such as priority review vouchers, paired with financial incentives such as tax credits, research funding and public–private investment matching, can encourage a wide range of stakeholders to invest in women’s health and help stimulate innovation.

A reimagined pricing and reimbursement model can also attract investment and address funding gaps.

The appropriate representation of women in clinical trials should be the top priority to improve women’s health outcomes. To ensure that new treatments are safe and effective in women, it is essential to improve their enrolment, especially in early-phase clinical trials and key therapeutic areas, such as cardiology and oncology.

Greater inclusion of underrepresented groups, including women of colour and post-menopausal women, is critical. The paper also proposes a maternal investigation framework that would mandate, where feasible, the inclusion of pregnant and lactating women and offer targeted research incentives.

Creating awareness among regulators and clinical trial staff about the importance of inclusion and how best to design inclusive clinical trials can accelerate the alignment of efforts to achieve shared goals.

Standardized data collection, consistent terminology and sex-specific benefit-risk assessments are necessary to provide better identification of unique sex-specific effects. Embracing flexible analytical methods and enabling global data sharing will help extract meaningful insights from smaller or limited datasets.

Education for investigators, developers, clinical trial staff and patients – along with improved clinical trial access, especially for women from underserved populations – is essential for advancing women’s health research. Clinical trials must also be designed to account for sex-based biological differences in treatment response and disease progression.

Clinical guidelines, drug labels and patient leaflets should reflect sex-specific safety and efficacy data. Scientific journals should also adopt and enforce the SAGER (Sex and Gender Equity in Research) reporting guidelines to improve transparency and accountability in published research.

By advancing these five policy levers, we can fundamentally reshape clinical research to better reflect critical physiological differences between men and women and promote better health outcomes for everyone. We know this kind of change is possible.

Over the last two decades, there have been examples of this kind of progress in rare diseases and paediatrics, where targeted interventions and incentives have transformed outcomes.

The time has come to bring that same ambition to women’s health. Governments, payers, research funders, investigators, regulators and healthcare leaders must unite to address the structural drivers of the women’s health research gap. Meaningful transformation will come from deep-rooted, coordinated, multi-stakeholder action across the health ecosystem.

The World Economic Forum’s Global Alliance for Women’s Health aims to unite these stakeholders around a common vision of robust, safe and inclusive science. The alliance is committed to encouraging the structural changes needed to progress clinical research, ensuring that innovation meets women’s diverse needs, preferences and lifestyles.