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Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind

January 26, 2023 @ 11:00 am - 12:00 pm EST

Pregnant and lactating populations are routinely left out of clinical trials, leaving these populations and their health care providers with a dearth of information about which vaccines or diagnostic devices may be safe and effective for both mother and baby.

The lack of information about the safety and efficacy of the COVID-19 vaccine for pregnant and lactating populations—due in part to poorly justified concerns about the safety of medications and vaccines during pregnancy—led to a significant delay in getting pregnant people included in clinical trials. As a result, these families missed an important health prevention opportunity, and may have suffered as a result. COVID-19, though one example, is not the only example of how excluding these populations has led to unanswered questions that could improve health outcomes for pregnant and lactating populations and their families.

During this congressional briefing and national webinar, panelists explored certain areas of research where the exclusion of these groups has resulted in an inability to support them, how federal research investments could improve outcomes, and where there is opportunity—both at the legislative and regulatory level—moving forward.

*This event is widely attended and relevant to official duties.

This event is part of a series about the inclusion of pregnant and lactating peoples in research. 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)

Details

Date:
January 26, 2023
Time:
11:00 am - 12:00 pm EST
Event Categories:
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Organizer

SWHR

Panelists

Anne Drapkin Lyerly, MD, MA
Professor, Social Medicine, Research Professor, OBGYN, University of North Carolina, Chapel Hill
Anne Drapkin Lyerly, MD, MA
Professor, Social Medicine, Research Professor, OBGYN, University of North Carolina, Chapel Hill

Annie Lyerly, MD, MA is Professor of Social Medicine at the University of North Carolina, Chapel Hill. She is also Research Professor in Obstetrics and Gynecology. Her research addresses socially and morally complex issues in women’s health and reproductive medicine, with a focus on how people assign meaning to reproductive events. A central goal of her work is to inform and reframe debates based on the views of those most profoundly affected by them, and to appropriately weight these individuals’ interests in shaping reproductive health care.

Dr. Lyerly has been supported by the National Institutes of Health, the Wellcome Trust, and the Greenwall Foundation, including its Faculty Scholars Program. Her work has appeared in numerous journals, including Science, JAMA, The New England Journal of Medicine, the Hastings Center Report, the Lancet, and The American Journal of Public Health, as well as the New York Times and Scientific American.

She served as Chair of the American College of Obstetricians and Gynecologists Committee on Ethics, and Co-chair of the Program Committee for the American Society of Bioethics and Humanities. She has also served as an advisor for a wide range of national and international organizations, including the World Health Organization, the March of Dimes, the United States Food and Drug Administration, and the U.S. Task Force Specific on Research Specific to Pregnant and Lactating Women, among others.

Christina Chambers, PhD, MPH
Professor, Pediatrics, School of Medicine at University of California San Diego; Chief, Division of Environmental Science and Health and Co-Director, Center for Better Beginnings
Christina Chambers, PhD, MPH
Professor, Pediatrics, School of Medicine at University of California San Diego; Chief, Division of Environmental Science and Health and Co-Director, Center for Better Beginnings

Dr. Christina Chambers is a Professor in the Department of Pediatrics, School of Medicine at University of California San Diego. She is Chief of the Division of Environmental Science and Health, and Co-Director of the Center for Better Beginnings. She is the principal investigator of MotherToBaby Pregnancy Studies, and the UC San Diego Human Milk Research Biorepository, two nation-wide longitudinal cohort studies focused on the safety of medications, vaccines, substances, infectious agents, and other environmental exposures in pregnancy and lactation. Dr. Chambers co-directs the HEALthy Brain and Child Development Study (HBCD), a nationwide research initiative focused on developmental trajectories of children in various environments from prenatal life through 10 years of age.

In addition, Dr. Chambers leads research and educational initiatives in the United States and internationally on the prevention and treatment of children with Fetal Alcohol Spectrum Disorders.  She co-directs the Center for Population Science and Community Engagement in the Clinical and Translational Research Institute at UC San Diego which supports clinical research development in diverse populations.

Kara Polen, MPH
Associate Director for Communications, Division of Birth Defects and Infant Disorders, Centers for Disease Control and Prevention
Kara Polen, MPH
Associate Director for Communications, Division of Birth Defects and Infant Disorders, Centers for Disease Control and Prevention

Kara Polen, MPH is the Associate Director for Communications in CDC’s Division of Birth Defects and Infant Disorders. In this role, she leads efforts to promote the Division’s surveillance and research findings on the impact of exposures during pregnancy. Her team also facilitates the translation of data into public health action on topics ranging from emerging threats during pregnancy to prenatal substance exposure. During CDC’s COVID-19 Response, Ms. Polen led communication for the Maternal Immunization Team on CDC’s Vaccine Task Force.

This webinar series is an initiative of the Coalition to Advance Maternal Therapeutics, administered by the Society for Women’s Health Research.