Federal, Private, and Nonprofit Resources: Inclusion of Pregnant and Lactating Populations in Research

Federal Research and Initiatives

• Task Force and Research Specific to Pregnant Women and Lactating Women (PRGLAC)
  • PRGLAC Website
  • PRGLAC Report to HHS Secretary and Congress, September 2018
  • List of Recommendations from the PRGLAC Report
  • PRGLAC Report Implementation Plan
• Implementing a Maternal Health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative | NICHD
• Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub | NICHD
• Pregnancy Research Initiatives | Food and Drug Administration Office of Women’s Health

Guidance Documents

• Clinical Lactation Studies: Guidance for Industry (May 2019) | FDA
• Postapproval Pregnancy Safety Studies: Guidance for Industry (May 2019) | FDA
• Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (April 2018) | FDA

Population-Based Surveillance and National Registries

• ClinicalTrials.gov
• List of Pregnancy Exposure Registries | FDA Office of Women’s Health
• Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)

Publications

• Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks (2024) | NASEM
  • Advancing Clinical Research with Pregnant and Lactating Populations: Slide Presentation from April 2024 Event with CAMT (2024) | NASEM
• Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop (2023) | NASEM
• Research with Pregnant and Lactating Populations: Mitigating Risk and Liability: Proceedings of a Workshop-in Brief (2023) | NASEM

Events

• Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks Report Launch Event (2024) | NASEM
• Inclusion of Pregnant and Lactating Persons in Clinical Trials: Workshop Highlights | NASEM