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Session 10: Post Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy
Session Chair(s)
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer
UBC, United States
Chelsea O'Connell, MS, RAC
Director, Global Regulatory Policy & Intelligence
Amgen, United States
Historically, regulators have required sponsors to collect pregnancy safety information in the post-marketing setting through prospective registries. However, pregnancy registries have practical barriers to enrolling subjects and often suffer from the lack of an adequate control group, inadequate power to achieve study objectives, high operational cost, a lack of generalizability, and long timelines before results are available to support clinical decisions.
There is increasing opportunity and ability for real-world data and real-world evidence (RWD/E) from claims and electronic health record (EHR) databases to address some of the challenges seen with registries and more efficiently answer the question of drug safety during pregnancy. Retrospective database studies allow for observation of patients representing a broad population – not just those self-selected for registry enrollment or referred by providers, and the larger sample size enables faster accumulation of data and ultimately insight into patient safety.
This session will discuss various fit-for-purpose pregnancy study options to inform a framework that includes prospective registries, retrospective database studies, and single-arm safety/enhanced pharmacovigilance studies with criteria dependent on the patient population in scope.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize challenges that occur in prospective pregnancy registries
- Describe opportunities that retrospective database studies bring to understanding drug safety during pregnancy
- Assess a future framework of fit-for-purpose pregnancy study options in the postapproval phase
Speaker(s)
Speaker
Leyla Sahin, MD
FDA, United States
Deputy Director for Safety, DPMH, OND, CDER
Speaker
Carrie Nielson, PhD, MPH
Amgen, United States
Observational Research Senior Manager
Speaker
Carla Jonker, MS
Medicines Evaluation Board (MEB), Netherlands
Senior Regulatory Project Leader
Global Challenges and Opportunities in Evaluating Peri-pregnancy Exposure and Safety Risks Through Database Studies
Krista F. Huybrechts, PhD, MS, FISPE
Harvard Medical School, United States
Associate Professor of Medicine and Epidemiology
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