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 authors conclude that 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.