Advancing maternal and perinatal health through clinical trials: key insights from a WHO global consultation

Pregnant and lactating women have long been excluded from participation in clinical research. This exclusion has resulted in the absence of high-quality evidence on the effectiveness and safety of medical products (medicines, vaccines, and other biological or biomedical products) during pregnancy and lactation, and fragmented health policies and practice recommendations. Based on the discussions at the inaugural WHO Global Clinical Trials Forum in November, 2023, a rapid review of key global, regional, or national ethical and regulatory documents, and previous expert consultations, this paper aims to summarise obstacles and suggest opportunities for appropriate inclusion of pregnant and lactating women in clinical trials. The main challenges identified relate to issues of: trial design; inconsistent interpretation and implementation of ethical, regulatory, and legal guidance; high costs of trials and low return on investments; insufficient research capacity and funding opportunities; misinformation; and insufficient community engagement. Appropriate inclusion is necessary and possible through: multi-stakeholder coordination; alignment with governance bodies to streamline ethical, regulatory, and legal processes for trial conduct; advocacy to prioritise investments in research; stronger focus on capacity strengthening; and good participatory practice that includes women and communities. A paradigm shift towards more inclusive and integrated research methodologies is urgently needed. This shift extends beyond pregnancy to transform the overall trial ecosystem and prioritise the health and wellbeing of all women and their infants everywhere, to truly achieve equitable access to health and innovations and leave no one behind.