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Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, due to a number of historical, ethical, legal, scientific, and societal issues, pregnant and lactating persons are often excluded from clinical trials. As a result, pregnant and lactating persons are often taking drugs based on limited information about the benefits and risks to themselves and their developing or newborn baby.

The National Academies Forum on Drug Discovery, Development, and Translation convened a workshop in June 2022 for stakeholders to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials. This publication summarizes the presentations and discussion of the workshop.

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National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26790.

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Publication Info

146 pages | 6 x 9 | Paperback
ISBN: 978-0-309-69637-1
DOI: https://doi.org/10.17226/26790
Chapters skim
Front Matter i-xviii
1 Introduction 1-8
2 Effects of Evidence Gaps in Clinical Treatment for Pregnant and Lactating Persons 9-18
3 The Legal Landscape 19-42
4 Lessons Learned 43-56
5 Potential Practical Solutions for Including Pregnant and Lactating Persons in Clinical Trials 57-64
6 Promising Innovative Approaches to Evidence Generation 65-78
7 A Path Toward Inclusion 79-88
Appendix A: References 89-92
Appendix B: Workshop Agenda 93-104
Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff 105-128

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