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Session 10: Insights into the Collection of Safety Data in Pregnancy
Session Chair(s)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases, University of Chicago, United States
Susan Kindig, JD, MD
Prior Executive Director, Medical and Drug Safety, United States
This session will focus on enhancing the collection of informative safety data on drug and vaccine use in pregnancy. Points that will be covered include:
- Ethical and scientific considerations for inclusion of pregnant women in clinical trials
- Novel approaches to collecting safety data about vaccine use in pregnancy (e.g. COVID vaccines, new RSV vaccine approved in August 2023)
- Core data elements for pregnancy pharmacovigilance studies using primary source data collection methods
Learning Objective : - Explain the ethical issues of both the exclusion and inclusion of pregnant women in clinical trials
- Describe the challenges and advancements of inclusion of pregnant women in clinical trials to generate primary data
- Identify the key data required to enable evaluation of the safety of a drug administered in pregnancy
- Discuss lessons learned regarding prior approaches to safety data collection following vaccination or drug use in pregnancy
Speaker(s)
Anne Drapkin Lyerly, MD, MA
Professor, Social Medicine Research; Professor, Obstetrics and Gynecology, University of North Carolina, United States
Ethical Considerations for the Collection of Safety Data in Pregnancy
Christine Olson, MD, MPH
Medical Officer, Immunization Safety Office/DHQP/NCEZID, Centers for Disease Control and Prevention, United States
CDC COVID-19 Vaccine Pregnancy Registry: Experience and Lessons Learned
Jonathan Luke Richardson, PhD
Principal Medical Information Scientist and Data Manager, UK Teratology Informat, UK Teratology Information Service, United Kingdom
Medication and Pregnancy - Improving safety data collection, data harmonisation and risk communication using outputs from the IMI ConcePTION project