Prescription for Change 2025

and other bioactive substances are properly evaluated – for all populations investigated. Applications should not advance without this analysis unless scientifically justified. Regular updates based on real-world evidence will keep clinical guidelines relevant, while standard statistical reporting with confidence intervals and controls for confounding variables can improve data reliability. –Adopt flexible methodologies for analysis and global data sharing to maximize insights from limited data. Using advanced statistical approaches, such as Bayesian methods, or synthetic data for in-silico modelling to power sample sizes while integrating real-world evidence will enable more accurate and timely evaluations of treatment safety and efficacy, particularly for under-represented populations. Additionally, sharing existing and future clinical trial data among regions and countries will enhance transparency, accelerate innovation and ensure that medical decisions are based on diverse, comprehensive datasets, ultimately improving global health outcomes. Improving data disaggregation will take several steps. The first is to harmonize terminology and define standardized data collection practices, ideally in collaboration with ICH. Once a clear framework is in place, regulators must establish concrete requirements for data analysis, ensuring that sex- specific differences are consistently assessed. Finally, addressing gaps in the limited data will require a coordinated effort among industry, regulators and other key stakeholders to implement flexible statistical approaches and incorporate real-world evidence. In taking these steps, a more inclusive and data-driven foundation for women’s health research can be built. Generating data that accurately represents the individuals receiving medicines is essential for making evidence-based decisions. We are committed to ensuring clinical research reflects the diversity of the populations we serve, thereby improving health outcomes for all. Alison Cave, Chief Safety Officer, Medicines and Healthcare products Regulatory Agency (MHRA) UK Prescription for Change: Policy Recommendations for Women’s Health Research 17