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Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Image

Inclusion of Pregnant
and Lactating Persons
in Clinical Trials

_____

Theresa Wizemann, Andrew March,
and Carolyn Shore, Rapporteurs

Forum on Drug Discovery,
Development, and Translation

Board on Health Sciences Policy

Health and Medicine Division

Proceedings of a Workshop

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by contracts between the National Academy of Sciences and Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Burroughs Wellcome Fund (Contract No. 1022279); Critical Path Institute; Eli Lilly & Co. (Contract No. 4900709231); FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable, Inc.; Merck & Co., Inc. (Contract No. APA-21-151620); National Institutes of Health (Contract No. HHSN263201800029I, Task Order No. HHSN26300007): National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Science Policy; New England Journal of Medicine; Sanofi (Contract No. 70602577); Takeda Pharmaceuticals; and the U.S. Food and Drug Administration (Grant No. 1R13FD007302-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-69637-1
International Standard Book Number-10: 0-309-69637-2
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Suggested citation: 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.

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

Rapid Expert Consultations published by the National Academies of Sciences, Engineering, and Medicine are authored by subject-matter experts on narrowly focused topics that can be supported by a body of evidence. The discussions contained in rapid expert consultations are considered those of the authors and do not contain policy recommendations. Rapid expert consultations are reviewed by the institution before release.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

PLANNING COMMITTEE ON INCLUSION OF PREGNANT AND LACTATING PERSONS IN CLINICAL TRIALS1

RUTH FADEN (Cochair), Founder, Johns Hopkins Berman Institute of Bioethics and Phillip Franklin Wagley Professor, Johns Hopkins University

SHIRLEY SYLVESTER (Cochair), Senior Medical Director, Women’s Health, Johnson & Johnson

KAVITA SHAH ARORA, Associate Professor and Division Director of General Obstetrics and Gynecology, University of North Carolina, Chapel Hill

EBONY BOYCE CARTER, Associate Professor of Maternal Fetal Medicine, Washington University in St. Louis School of Medicine

NAHIDA CHAKHTOURA, Medical Officer, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health

WILLIAM COOPER, Professor of Pediatrics and Health Policy, Vanderbilt University

BROWNSYNE TUCKER EDMONDS, Associate Professor and Obstetrics and Gynecology, Indiana University

DARCIE EVERETT, Medical Officer, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

LESLIE MELTZER HENRY, Professor of Law, University of Maryland

STEVEN KERN, Deputy Director, Quantitative Sciences, Bill & Melinda Gates Foundation

LEYLA SAHIN, Deputy Director for Safety, Division of Pediatrics and Maternal Health, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

DIANE SPATZ, Professor of Perinatal Nursing and Nutrition, University of Pennsylvania

RAMAN VENKATARAMANAN, Professor of Pharmaceutical Sciences and Pathology, University of Pittsburgh

MICHELLE VICHNIN, Executive Director, Global Patient Advocacy and Strategic Alliances, Merck & Co.

CARMEN ZORRILLA, Interim Dean of Research and Professor of Obstetrics and Gynecology, University of Puerto Rico

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

Health and Medicine Division Staff

CAROLYN K. SHORE, Director, Forum on Drug Discovery, Development, and Translation

DEANNA GIRALDI, Associate Program Officer

ANDREW MARCH, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

CLARE STROUD, Senior Director, Board on Health Sciences Policy (from June 2022)

ANDREW M. POPE, Senior Director, Board on Health Sciences Policy (until June 2022)

Consultants

THERESA WIZEMANN, Science Writer

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

GREGORY SIMON (Cochair), Kaiser Permanente Washington Health Research Institute and University of Washington

ANN TAYLOR (Cochair), Retired

CHRISTOPHER P. AUSTIN, Flagship Pioneering

LINDA BRADY, National Institute of Mental Health, NIH

JOHN BUSE, University of North Carolina School of Medicine

LUTHER CLARK, Merck & Co., Inc.

BARRY S. COLLER, The Rockefeller University

THOMAS CURRAN, Children’s Mercy, Kansas City

RICHARD DAVEY, National Institute of Allergy and Infectious Diseases, NIH

KATHERINE DAWSON, Biogen

JAMES H. DOROSHOW, National Cancer Institute, NIH

JEFFREY M. DRAZEN, New England Journal of Medicine

STEVEN K. GALSON, Retired

CARLOS O. GARNER, Eli Lilly and Company

DEBORAH HUNG, Harvard Medical School

LYRIC JORGENSON, Office of Science Policy, NIH

ESTHER KROFAH, FasterCures, Milken Institute

LISA M. LAVANGE, University of North Carolina

ARAN MAREE, The Janssen Pharmaceutical Companies of Johnson & Johnson

CRISTIAN MASSACESI, AstraZeneca

ROSS MCKINNEY JR., Association of American Medical Colleges

JOSEPH P. MENETSKI, Foundation for the National Institutes of Health

ANAEZE OFFODILE, University of Texas MD Anderson Cancer Center

SALLY OKUN, Clinical Trials Transformation Initiative

ARTI RAI, Duke University School of Law

MARK ROGGE, University of Florida

KLAUS ROMERO, Critical Path Institute

JONI RUTTER, National Center for Advancing Translational Sciences, NIH

SUSAN SCHAEFFER, Patients’ Academy for Research Advocacy

JOSEPH SCHEEREN, Retired

ANANTHA SHEKHAR, University of Pittsburgh

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

JAY SIEGEL, Retired

ELLEN V. SIGAL, Friends of Cancer Research

MARK TAISEY, Amgen Inc.

AMIR TAMIZ, National Institute of Neurological Disorders and Stroke, NIH

PAMELA TENAERTS, Medable, Inc.

MAJID VAKILYNEJAD, Takeda Pharmaceutical Company, Inc.

JONATHAN WATANABE, University of California Irvine School of Pharmacy and Pharmaceutical Sciences

ALASTAIR WOOD, Vanderbilt University

JANET WOODCOCK, U.S. Food and Drug Administration

CRISPIN WOOLSTON, Sanofi

Forum Staff

CAROLYN K. SHORE, Forum Director

BIANCA ESPINOSA, Associate Program Officer (from July 2022)

DEANNA GIRALDI, Associate Program Officer (until September 2022)

ANDREW MARCH, Associate Program Officer

ASHLEY BOLOGNA, Senior Program Assistant (from July 2022)

MELVIN JOPPY, Senior Program Assistant

CLARE STROUD, Senior Director, Board on Health Sciences Policy (from June 2022)

ANDREW M. POPE, Senior Director, Board on Health Sciences Policy (until June 2022)

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

CHRISTINA BUCCI-RECHTWEG, Novartis Pharmaceuticals Corporation

JOSÉ F. CORDERO, University of Georgia

MARNI HALL, IQVIA

ANNA MASTROIANNI, Johns Hopkins University

ELAD SHARON, National Cancer Institute, National Institutes of Health

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings, nor did they see the final draft before its release. The review of this proceedings was overseen by ELLEN WRIGHT CLAYTON, Vanderbilt University Medical Center. She was responsible for making certain that an independent examination of this proceedings

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×

Acknowledgments

Support from the sponsors of the Forum on Drug Discovery, Development, and Translation is crucial to support this and other work of the National Academies.

The National Academies’ staff wish to express their gratitude to the speakers whose presentations helped inform workshop discussions on the opportunities to improve the inclusion of pregnant and lactating persons in clinical trials; to the members of the planning committee for their work in developing the workshop agenda and shaping the discussions; and to additional National Academies staff, without whom this workshop and the accounting thereof would not have been possible: Christie Bell, Samantha Chao, Robert Day, Rebekah Hanover Pettit, Benjamin Hubbert, Devona Overton, Marguerite Romatelli, Bettina Seliber, Lauren Shern, Maya Thirkill, Elizabeth Webber, and Taryn Young.

Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
×
Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Page xvii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Abbreviations and Acronyms

AAP American Academy of Pediatrics
ACOG American College of Obstetrics and Gynecology
BPCA Best Pharmaceuticals for Children Act
CDER Center for Drug Evaluation and Research (FDA)
EHR electronic health record
FDA U.S. Food and Drug Administration
FDAMA Food and Drug Administration Modernization Act
FD&C Food, Drug, and Cosmetic Act
GBS group B Streptococcus
IRB institutional review board
JHU Johns Hopkins University
MPRINT Maternal and Pediatric Precision in Therapeutics
NICHD National Institute of Child Health and Human Development (NIH)
NIH U.S. National Institutes of Health
Page xviii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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OBGYN obstetrician/gynecologist
PHASES Pregnancy and HIV/AIDS: Seeking Equitable Study
PREA Pediatric Research Equity Act
PREVENT Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies
PRGLAC Task Force on Research Specific to Pregnant Women and Lactating Women
RSV respiratory syncytial virus
SOP standard operating procedure
SSRI selective serotonin reuptake inhibitor
SWHR Society of Women’s Health Research
UW University of Washington
Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26790.
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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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