DIA 2022 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-554-L04-P ; CME 1.00; RN 1.00

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 future framework that includes prospective registries, retrospective database studies, single-arm safety studies or enhanced pharmacovigilance with criteria dependent on the patient population in scope. In addition, the recent EMA guideline on good pharmacovigilance practices for pregnancy prevention programs will be discussed.

Learning Objectives

Discuss fit-for-purpose pregnancy safety study options including prospective registries, real-world data retrospective database studies, single-arm safety studies, enhanced pharmacovigilance or a combination of studies to inform a future framework for pregnancy safety studies; Describe industry, FDA, and EMA current thinking of various study types, criteria, and requirements for post-approval pregnancy safety studies.

Chair

Chelsea O'Connell, MS, RAC

Speaker

FDA Perspective: Postapproval Safety Studies in Pregnant Individuals
Leyla Sahin, MD

Assessing Need and Effectiveness of Pregnancy Prevention Programs: A Crucial Piece of the Jigsaw
Priya Bahri, PhD, RPh

Fit-for-Purpose Pregnancy Safety Study Designs: Considerations for Developing a Framework
Rohini Hernandez, PhD, MPH

Barriers and Future Considerations to Generating Meaningful Safety Data from Post-Approval Safety Studies in Pregnancy
Lockwood Taylor, PhD, MPH