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A pregnant woman in Romania.
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Knowledge portal for inclusion of 
pregnant and lactating women in clinical trials

Pregnant and lactating women have historically been excluded from clinical research, resulting in substantial gaps in high-quality evidence on the safety and efficacy of medications and vaccines during these critical periods. This exclusion has led to fragmented health policies and inconsistent clinical recommendations for prevention and treatment.

To address these inequities, the World Health Assembly adopted Resolution WHA75.8 in May 2022. This resolution calls for the transformation of clinical trial practices to promote collaboration, equity, and the standardization of research processes for under-represented populations, including pregnant and lactating women and children. Further emphasizing this need, the inaugural WHO Global Clinical Trials Forum in November 2023 highlighted the urgency of including these groups in clinical research.

To support this transformation, the WHO Pregnant and Lactating Women (PLW) Task Force has developed this disease agnostic, living knowledge portal. 

This knowledge portal supports researchers, program implementers, and other stakeholders by providing practical, adaptable resources and overarching guidance to promote the inclusion of pregnant and lactating women in clinical trials and related research involving preventive and therapeutic medicines, vaccines, and biologicals. It includes both cross-cutting, disease-agnostic strategies and targeted guidance for specific disease areas, such as HIV and TB, and vaccines, among others.

While this document uses the terms 'woman' and 'mother' in some contexts, we acknowledge and respect that not all individuals who experience pregnancy identify with these terms. This toolkit is intended to be inclusive of all people who experience pregnancy, regardless of their gender identity.

 

Objectives

Foster best practices

Foster best practices in research and development that ensure the safety and well-being of pregnant and lactating women.

Centralize resources

Create a centralized resource with information and tools on the inclusion of pregnant and lactating women in clinical research. 

Support study design

Support researchers, ethics committees, programme implementers and community representatives in designing studies involving pregnant and lactating women.

Research-based advocacy

Stimulate advocacy for the protection of pregnant and lactating women through research.

Knowledge portal components

Thematic areas

These thematic toolkits of the knowledge portal provide tailored guidance that reflects the unique clinical, pharmacological, and public health aspects of different conditions, while also capturing important differences between therapeutics, vaccines, and biologics.   

 

Abbreviations

DART development and reproductive toxicology

EFD embryo–fetal development

EFV efavirenz

EMA European Medicines Agency

ePPND enhanced pre- and postnatal development

FDA U.S. Food and Drug Administration (United States of America)

FEED fertility and early embryonic development

GAIA Global Alignment of Immunization Safety Assessment in Pregnancy

ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

PD Pharmacodynamic

PK Pharmacokinetic

PPND pre- and postnatal development

WHO World Health Organization

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Acknowledgements

The World Health Organization (WHO) gratefully acknowledges the contributions that many individuals and partner organizations have made to the development of this knowledge portal. 

The development of the technical content was initiated, coordinated and developed by: Mariana  Widmer, Martina Penazzato, Mercedes Bonet, Maria Barreix and Teesta Dey from WHO Department of Sexual, Reproductive, Maternal, Child, Adolescent and Aging Health and Science for Health Department with substantial technical contributions provided by wider members of the WHO Pregnant and Lactating Women Task Force (in alphabetical order): Rodrigo Cataldi, Doris Chou, Ayesha De Costa, Valeria Gigante. Ameena Goga, Marion Laumonier, Katherine Littler, Francoise Renaud, Carla Saenz, Smaragda Lamprianou, Anthony Solomon, Claire Townsend, Sabine Verkuijl, and Kerri Viney.

WHO sincerely thanks the following external collaborators for their contributions and input in reviewing the content of the knowledge portal (in alphabetical order): Elaine Abrams (Columbia University, United States of America), Becky Barry (United States of America), Barbara Bierer (Harvard Medical School, United States of America), Angela Colbers (Radboudumc, the Kingdom of  the Netherlands), Estela Countinho (Global Foundation for the Care of Newborn lnfants, Germany), Natalie Dayan (McGill University, Canada), Emily Doerksen (McGill University, Canada), Myriam El Gaaloul (Medicines for Malaria Venture, Switzerland), Ruth Faden (Johns Hopkins Berman Institute of Bioethics, United States of America), Jennifer Furin (Sentinel Project on pediatric drug-resistant tuberculosis, United States of America), Shivaprasad Goudar (Jawaharlal Nehru Medical College, India), Justus Hofmeyr (University of the Witwatersrand, South Africa), Jennifer Hughes (Stellenbosch University, South Africa), Pete Lambert (Monash University, Australia), Cornelia Landersdorfer (Monash University, Australia), Andrea Lucard (Concept Foundation, Switzerland), Anna Mastroianni (Johns Hopkins Berman Institute of Bioethics, United States of America), Lynne Mofenson (Independent Consultant, United States of America), Rose Mwangi (McGill University, Canada), Kirsten Palmer (Monash University, Australia), Sara Rushwan (Concept Foundation, Switzerland), Nicole Salazar-Austin (Johns Hopkins University, United States of America), Agnes Saint Raymond (Independent Consultant, France), Dave Shackleford (Monash University, Australia), Marta Fernandez Suarez (Concept Foundation, Switzerland), Claire Thorne (University College London, United Kingdom of Great Britain and Northern Ireland), Craig Tipple (Drugs for Neglected Diseases Initiative, Switzerland).

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Methods

The development of this knowledge portal involved evidence synthesis from global ethics and good clinical practice documents and best practice statements. Content was expertly reviewed by a multi-stakeholder panel for accuracy and completeness.

All external experts signed declarations of interest, disclosing to the WHO any potential conflicts of interest that might influence or could reasonably be perceived to influence their objectivity and independence in relation to the content of the toolkit. WHO thoroughly reviewed each declaration and determined that none posed an actual or reasonably perceived conflict of interest concerning any aspect of the toolkit.

This work was funded by UK Department of Health and Social Care. The views of the funding body have not influenced the content of this knowledge portal.


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