On February 24, 2021, the Coalition to Advance Maternal Therapeutics (CAMT) and its member organizations, including the Society for Birth Defects Research and Prevention, hosted a virtual Capitol Hill Briefing on the need to increase inclusion of pregnant and lactating people in clinical trials using the ongoing COVID-19 pandemic as a case study.
Each year in the United States, six million people become pregnant, nearly four million give birth, and more than three million initiate breastfeeding with little research on the safety, efficacy, and appropriate dosing for their vital therapeutics. More than 90 percent of pregnant people report taking a medication during pregnancy; only 1 percent of clinical trials mention the word pregnancy or pregnant and only 0.5 percent mention breastfeeding or lactation. In the context of COVID-19, pregnant and lactating people were largely excluded from clinical trials for treatments and vaccines, leaving them and their clinicians without clear guidance on the safety and efficacy to guide clinical decision-making. We can and must do better for pregnant and lactating people.
In 2018, PRGLAC released a Report to Congress that included 15 detailed recommendations to promote the inclusion of pregnant and lactating people in clinical trials. PRGLAC took these recommendations further in its implementation report to the Secretary of Health and Human Services released in August 2020. The February 24 briefing provided an opportunity for those on Capitol Hill and beyond to learn more from researchers, clinicians, and patients about how to improve these issues in the context of COVID and beyond.
Dr. Rahul Gupta, SVP & Chief Medical and Health Officer for March of Dimes, moderated the panel.
Dr. Diana Bianchi, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), provided an overview of PRGLAC’s recommendation and implementation plan and provide highlights of NICHD activities to promote inclusion and advance clinical research.
Dr. Emily S. Miller, Assistant Professor, Department of Obstetrics & Gynecology at Northwestern University, discussed her experiences treating patients during the COVID-19 pandemic.
Dr. Jacqueline G. Parchem, Assistant Professor, Department of Obstetrics at University of Texas, offered both professional and personal insights as a doctor and pregnant person who decided to receive the COVID-19 vaccine.
- Briefing Recording
- Panelist Slides
- Panelist Bios
- CAMT Backgrounder
- JAMA Commentary authored by NICHD Director Diana Bianchi and colleagues: Involving Pregnant Individuals in Clinical Research on COVID-19 Vaccines
- PRGLAC Website
BDRP members who would like to know more about the Society's efforts related to PRGLAC or would like to get involved should contact Janet Hardy or Melissa Tassinari, the co-chairs of the joint BDRP-OTIS PRGLAC Workgroup.