Expand the inclusion of women in clinical trials2 The appropriate representation of women in clinical trials should be the top priority to improve women’s health outcomes. Despite women experiencing various medical conditions differently and disproportionately compared to men, sex-specific research is lacking. In the 1950s and early 1960s, thalidomide was prescribed to pregnant women to treat morning sickness, but it led to severe birth defects including children being born with missing or malformed limbs.27 This prompted the exclusion of women of childbearing age from clinical trials for almost four decades and is one of the main reasons for a gaping hole in clinical research focused on women and their unique health outcomes. Additionally, females are often ignored and only seen as small males in both animal and human studies – another reason for the huge gap in women’s health research. It was not until 1993, when the NIH mandated women’s inclusion in trials, that women began to be more widely represented in clinical trials. However, even though the representation of women in clinical trials has been increasing in recent years, women remain under-represented in early clinical trials, potentially creating significant gaps on dosing accuracy and consequently safety and efficacy, and in important therapeutic areas such as cardiology and oncology, despite the high disease burden in those areas.28 Further to this, key subpopulations such as women of colour and post-menopausal women remain under-represented in clinical trials.29,30 Meanwhile, only 5% of available medications have been adequately monitored, tested and labelled with safety information for use in pregnant and breastfeeding women, and as such more than 80% of pregnant patients are routinely prescribed therapies that have never been studied during pregnancy or lactation.31,32 All of these discrepancies highlight a critical oversight in women’s health science and innovation (Figure 4).2.1 Women remain under-represented in clinical trials Inclusion of pregnant and lactating women in clinical trials FIGURE 4 Source: Innovative Medicines Initiative. Background. IMI ConcePTION. https://www.imi-conception.eu/ background/Drugs labelled for use in pregnant and lactating women 5% Prescription for Change: Policy Recommendations for Women’s Health Research 12

Prescription for Change 2025