WHO Launches Portal to Include Pregnant Women in Clinical Trials

The World Health Organization (WHO) and its Human Reproduction Program (HRP) are set to launch a new knowledge portal to promote the inclusion of pregnant and lactating women in clinical trials. The initiative aims to address gaps in medical evidence and support the safe, ethical and equitable participation of these women in clinical research.

Pregnant and breastfeeding women have historically been excluded from many clinical studies, leaving limited evidence on the safety and effectiveness of medicines and vaccines during pregnancy and lactation.

This lack of data creates challenges for healthcare professionals making treatment decisions and can lead to the use of medicines without sufficient evidence specific to these groups. According to a WHO report published in June 2025, only 4% of clinical trials registered over the preceding decade allowed pregnant women to participate.

Key Highlights:

• WHO and HRP launch a portal to promote the inclusion of pregnant and lactating women in clinical trials
• Only 4% of clinical trials allowed pregnant women to participate, according to a 2025 WHO report
• The portal provides resources to support ethical research and informed healthcare decisions

It will bring together scientific, ethical and operational tools and resources to help researchers, regulators, ethics committees, product developers and other stakeholders in responsible inclusion practices. It will give practical information to help overcome issues with the participation of pregnant women and women who are breastfeeding in clinical research.

This is indicative of increasing awareness that there is no cure for the risks of medical treatment by excluding these groups from clinical trials. Rather, it can result in women and health care providers having few evidence-based resources for decision making about medicines and vaccines during pregnancy and breastfeeding. The creation of reliable research evidence can assist with better clinical advice and advice to more effectively inform treatment choices.

WHO and HRP have been collaborating on ways to help support the global call for early and appropriate involvement of pregnant and breastfeeding women in research and development. In 2025, WHO declared a global task force to address age-old challenges and facilitate these populations to be able to join clinical trials of medical products by 2030. The initiative is part of broader efforts to enhance the representation of under-represented groups and the clinical trial process.

The knowledge portal will be launched at a WHO webinar on 9th October 2026 from 1:30 pm to 3 pm Central European Time. The session will highlight the role of the portal, scope and applications and place it in the context of activities in the international arena to enhance clinical research. It will also give an opportunity to stakeholders to consider how the resources can be used in various contexts.

WHO and HRP aim to offer support to the stakeholders to encourage responsible research practices and strengthen the evidence base for decisions that affect the health of pregnant women, lactating mothers and their newborns via the portal.