Inclusion of Pregnant and Lactating Persons in Clinical Trials

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.

Table of Contents

Front Matter 1 Introduction 2 Effects of Evidence Gaps in Clinical Treatment for Pregnant and Lactating Persons 3 The Legal Landscape 4 Lessons Learned 5 Potential Practical Solutions for Including Pregnant and Lactating Persons in Clinical Trials 6 Promising Innovative Approaches to Evidence Generation 7 A Path Toward Inclusion Appendix A: References Appendix B: Workshop Agenda Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff