Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research

Pregnant and lactating women have historically been excluded from clinical trials. Federal policies from the 1970s that excluded “women of childbearing age” from research led research to use male participants, limiting our knowledge base. Although a 1994 report from the Institute of Medicine recommended that pregnant women be presumed to be eligible to participate in clinical studies and that lactating women not be excluded from clinical studies, concerns remain about including pregnant and lactating populations in research.

During this virtual congressional briefing and national webinar, panelists reviewed ethical considerations surrounding inclusion of pregnant and lactating women in research, how to ensure the appropriate inclusion of these populations, and the current state of this type of inclusion in research, both within the federal government and the corporate sector.

Panelists

• Drew Hatter (Moderator), Federal Affairs Strategist, American College of Obstetricians and Gynecologists (ACOG)
• Christina Bucci-Rechtweg, MD, Head, Pediatric & Maternal Health Policy, Global Drug Development and Regulatory Affairs, Novartis Pharmaceutical Corporation
• Aaron Pawlyk, PhD, Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Leyla Sahin, MD, Deputy Director for Safety, Division of Pediatrics and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
• Catherine Spong, MD, Professor and Chair, Department of Obstetrics and Gynecology; Chief, Division of Maternal Fetal Medicine; Paul C. MacDonald Distinguished Chair in Obstetrics and Gynecology, University of Texas Southwestern Medical Center

This event is part of a series about the inclusion of pregnant and lactating peoples in research hosted by the Coalition. The full series includes:

• Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6, 2022)
• Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26, 2023)
• PRGLAC Then and Now: Where We Are and Where We’re Going (February 14, 2023)