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

Teesta Dey¹, Mariana Widmer², Arri Coomarasamy³, Shivaprasad S Goudar⁴, Mabel Berrueta⁵, Estela Coutinho⁶, Myriam El Gaaloul⁷, Ruth R Faden⁸, A Metin Gülmezoglu⁹, G Justus Hofmeyr¹⁰, Marian Knight¹¹, Smaragda Lamprianou¹², Anna C Mastroianni⁸, Flor M Munoz¹³, Olufemi T Oladapo², Martina Penazzato¹⁴, Françoise Renaud¹⁵, Claire L Townsend¹⁵, Mercedes Bonet²

Affiliations

¹ UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland. Electronic address: deyt@who.int.
² UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.
³ Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁴ Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India; Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.
⁵ Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.
⁶ European Foundation for the Care of Newborn Infants, Munich, Germany.
⁷ Medicines for Malaria Venture, Geneva, Switzerland.
⁸ Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
⁹ Concept Foundation, Geneva, Switzerland.
¹⁰ Department of Obstetrics and Gynaecology, University of Botswana, Gaborone, Botswana; Effective Care Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Obstetrics and Gynaecology, Walter Sisulu University, East London, South Africa.
¹¹ National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
¹² Pharmacovigilance Team, Regulation and Prequalification Department, Access to Medicines and Health Products Division, WHO, Geneva, Switzerland.
¹³ Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
¹⁴ Research for Health Department, Science Division, WHO, Geneva, Switzerland.
¹⁵ Department of Global HIV, Hepatitis and STI Programmes, WHO, Geneva, Switzerland.

PMID: 40155111
DOI: 10.1016/S2214-109X(24)00512-6

Free article

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

Teesta Dey et al. Lancet Glob Health. 2025 Apr.

Free article

. 2025 Apr;13(4):e740-e748.

doi: 10.1016/S2214-109X(24)00512-6.

Authors

Affiliations

¹ UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland. Electronic address: deyt@who.int.
² UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Sexual and Reproductive Health and Research, WHO, Geneva, Switzerland.
³ Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁴ Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India; Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.
⁵ Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.
⁶ European Foundation for the Care of Newborn Infants, Munich, Germany.
⁷ Medicines for Malaria Venture, Geneva, Switzerland.
⁸ Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.
⁹ Concept Foundation, Geneva, Switzerland.
¹⁰ Department of Obstetrics and Gynaecology, University of Botswana, Gaborone, Botswana; Effective Care Research Unit, University of the Witwatersrand, Johannesburg, South Africa; Department of Obstetrics and Gynaecology, Walter Sisulu University, East London, South Africa.
¹¹ National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
¹² Pharmacovigilance Team, Regulation and Prequalification Department, Access to Medicines and Health Products Division, WHO, Geneva, Switzerland.
¹³ Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
¹⁴ Research for Health Department, Science Division, WHO, Geneva, Switzerland.
¹⁵ Department of Global HIV, Hepatitis and STI Programmes, WHO, Geneva, Switzerland.

PMID: 40155111
DOI: 10.1016/S2214-109X(24)00512-6

Abstract

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.

Copyright © 2024 World Health Organization. Published by Elsevier Ltd. This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.

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Conflict of interest statement

Declaration of interests EC has received payments for expert testimonies from European Foundation for the Care of Newborn Infants (EFCNI) and University of Edinburgh; support for attending meetings and travel from EFCNI; and is a member of the Parent & Patient Advisory Board of EFCNI. AMG is the Executive Director of Concept Foundation; has received a grant from Bill & Melinda Gates Foundation entitled Accelerating Innovation for Mothers, coordinating a range of activities including maternal health products pipeline analyses and developing target product profiles. GJH has received royalties from Maternova. MK is a member of the WHO Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials. ACM has received grants awarded to Johns Hopkins University from the US National Institute of Health (NIH) and Wellcome Trust; and support for travel from The National Academies of Sciences, Engineering, and Medicine, and WHO. FMM has received grants awarded to Baylor College University from NIH and US Center for Disease Control and Prevention for COVID-19 vaccines and respiratory viruses in pregnant women and children, and from Pfizer and Gilead for COVID-19 research projects in children; is a member of Moderna's Vaccine and Pfizer's and Meissa's (respiratory syncytial virus vaccines) Data Safety Monitoring Boards; and has received consulting fees from Sanofi, AstraZeneca, Merck, and GSK. All other authors declare no competing interests.

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

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Medical