Pregnant and lactating women have historically been excluded from clinical research, resulting in significant gaps in evidence on the safety and efficacy of medicines and vaccines used during pregnancy and breastfeeding. This exclusion has contributed to uncertainty in clinical decision‑making and widespread off‑label use, with potential risks for women and their infants.
There is increasing recognition that excluding pregnant and lactating women from research does not eliminate risk, but rather shifts it into real‑world settings where evidence is limited. Ethical and public health frameworks now emphasize the need to protect women and their infants through research, while ensuring that such research is conducted in a safe, ethical and equitable manner.
In response, the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) and World Health Organization (WHO) have developed a new knowledge portal to support the timely inclusion of pregnant and lactating women in clinical trials. The portal brings together ethical, scientific and operational resources to support researchers, regulators, ethics committees, product developers and other stakeholders in advancing responsible inclusion practices.
This webinar will launch the knowledge portal and introduce its purpose, scope and practical application. It will also situate the portal within broader global efforts to strengthen the clinical trials ecosystem and ensure the inclusion of under‑represented populations in research. The event will provide an opportunity for dialogue among stakeholders and reflection on how the portal can support implementation in different contexts.
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