Bridging the gap: advancing inclusive research for pregnant and lactating women in global health R&D

Pregnant and lactating women have long been excluded from clinical research, forcing individual women and clinicians to make treatment decisions with insufficient evidence. This report seeks to characterise the extent of the evidence gap by focusing on HIV/AIDS, malaria and Zika, analysing the proportion of investment and clinical trials that include pregnant and lactating women.

• Pregnant and lactating women have traditionally been excluded from clinical research, leading to an enormous data gap when it comes to safety and efficacy of medication in pregnancy: more than 98% of drugs have insufficient pharmacokinetic or safety data to guide dosing in women who are pregnant or breastfeeding.
• Reluctance to include this population in clinical research stems from the perception of higher risks linked to infant drug exposure and altered drug pharmacokinetics. However, not conducting research leads to a lack of safety and efficacy data, which shifts the risk at the individual level, with women and clinicians having to make uninformed decisions about medical care during pregnancy.
• Between 2007 and 2024, less than 1% of funding for R&D for neglected diseases and emerging infectious diseases was identified as including pregnant and lactating women. Investment focused on 8 out of 47 different conditions, despite all of them affecting this population.
• R&D including pregnant and lactating women focuses on drug research compared to vaccines and biologics, and late-stage development (post-registration trials and Phase III trials), rather than experimental R&D. This reflects the legacy of the 1970s ban of pregnant women from Phase I and II trials, despite its retraction in the 1990s and regulatory authorities having since promoted more inclusive clinical research.  
• Only 2% of clinical trials conducted between 2007 and 2024 for malaria, HIV/AIDS and Zika included pregnant and lactating women, despite the unique burden of these conditions on this population and their babies.
• A multi-faceted approach is required to address the multiple issues that affect the inclusion of pregnant and lactating women in clinical research. This includes regulatory harmonisation, financial de-risking of inclusive research, and clinical trial capacity strengthening. A major paradigm shift in prevailing attitudes and beliefs is needed to overcome institutional and cultural obstacles and the neglect of this population in clinical research.