Advancing Women’s Health: From Dialogue to Durable Change
Posted on: Tuesday 3 March 2026
International Women’s Day (Sunday 8 March) offers an opportunity to reflect on the progress made, and on the work still required to ensure that medicines are safe, effective, and equitable for women.
At last year’s FPM Annual Symposium, the Women’s Health Deep Dive session examined how women’s health is shaped not only by disease burden, but by how evidence is generated across the drug development lifecycle.
The session highlighted a clear reality: while awareness and regulatory attention are increasing, measurable gaps in research design and participation remain.
Where the Evidence Falls Short
Across multiple therapeutic areas, disparities are evident:
- Despite cardiovascular disease being a leading cause of mortality in women, historical analyses show that women have often been inadequately represented in cardiovascular trials and that sex-specific analyses have not been consistently performed.1
- UK data (2019–2023) analysing over 4,600 trials found pregnant women included in just 1.1% of studies and breastfeeding women in 0.6%.2
- Autoimmune diseases disproportionately affect women, yet clinical trial recruitment does not consistently reflect this epidemiology.
These patterns extend across oncology, neurology, respiratory disease, cardiometabolic conditions, and mental health.
The implications are significant. Under-representation reduces the power of subgroup analyses. When sex-specific pharmacokinetic and safety analyses are not pre-specified, conclusions may rely on extrapolation. When study populations do not reflect real-world epidemiology, the applicability of evidence is constrained.
This is less a question of intent than of design.
A Lifecycle Perspective
Imbalance can accumulate across the research pathway:
- Pre-clinical models that predominantly use male animals
- Eligibility criteria that inadvertently create participation barriers
- Recruitment strategies that fail to address representational gaps
- Risk frameworks that do not fully account for sex-specific disease patterns
By the time medicines enter routine clinical use, these cumulative factors influence the strength and applicability of the available evidence.
Strengthening Methodological Practice
Progress is underway. Regulatory guidance on diversity and inclusion, the UK Women’s Health Strategy, and growing academic focus on sex and gender equity reflect increasing alignment.
Translating this into consistent practice requires methodological attention, including:
- Monitoring recruitment patterns to better reflect disease epidemiology
- Incorporating sex-disaggregated analyses prospectively within study design
- Strengthening pregnancy registries and post-marketing surveillance
- Leveraging national data infrastructure to identify under-served populations
- Ensuring digital health tools and AI systems are developed using representative datasets
- Integrating women’s lived experiences into research design and evaluation
These measures enhance scientific rigour and improve the applicability of evidence across the population.
The Role of Pharmaceutical Medicine
Pharmaceutical physicians work at the interface of science, regulation and patient safety. Decisions made in protocol development, eligibility criteria, data analysis and safety oversight shape who is represented in clinical evidence.
International Women’s Day provides a timely reminder that advancing women’s health requires sustained attention to how evidence is generated, interpreted and applied.
Women’s health is not peripheral to mainstream medicine – it is integral to it. Ensuring that the evidence base reflects this reality is fundamental to delivering safe and effective medicines for all.
On this International Women’s Day, we recognise the expertise, leadership and contributions of women across pharmaceutical medicine, and reaffirm our collective commitment to advancing women’s health through rigorous science and responsible clinical development.
References
1. Liu, K. A., & Mager, N. A. (2016). Women’s involvement in clinical trials: historical perspective and future implications. Pharmacy practice, 14(1), 708. https://doi.org/10.18549/PharmPract.2016.01.708
2. Manfrin, A., Lee, K., Pound, J., Pirmohamed, M., & Raine, J. (2025). Analysis of 4616 clinical trial initial submissions received by the Medicines and Healthcare products Regulatory Agency between February 2019 and October 2023. British journal of clinical pharmacology, 91(9), 2524–2533. https://doi.org/10.1002/bcp.70061