Hot Topic: Emerging Use of Real World Data to Address Data Gaps in Clinical Pharmacology: Opportunities & Challenges

Monday, October 17, 2022

2:30 PM – 3:30 PM ET

Location:153 A

Hot Topic Moderator(s)

Simon Dagenais, PhD, MSc

Senior director, RWE COE
Pfizer
New York, New York

Hot Topic Speaker(s)

Abie Ekangaki, PhD

Vice President, Statistical Consulting
Premier Research, North Carolina
Marc Gastonguay, PhD

CEO
Metrum Research Group
Tariffville, Connecticut
Simon Dagenais, PhD, MSc

Senior director, RWE COE
Pfizer
New York, New York

This session will provide an overview of real world data (RWD) and real world evidence (RWE) in the United States (US), including provisions related to RWE in the 21st Century Cures Act, common types of RWD, variables commonly available in RWD, and regulatory approvals based on RWE in the US. This session will then provide several examples of how RWD can be analyzed to answer questions that may be relevant to a clinical pharmacology audience, including extrapolating a dose from adults to pediatric populations using RWD, simulating clinical trials using RWD, and creating a pharmacometric model to support pediatric dosing based on RWD.

Learning Objectives:

Understand how the 21st Century Cures Act spurred interest in real world data (RWD) and real world evidence (RWE) in the United States.
Learn basic terminology related to RWD and RWE.
Recognize common types of RWD available in the US
Appreciate examples of how RWD can be used to answer research questions that arise in clinical pharmacology