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Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence
Session Chair(s)
Gregory Daniel, PHD, MPH
Vice President, Head of Public Policy Innovation and Evidence, Eli Lilly and Company, United States
The last several years have seen increasing effort to better understand when and how real-world data and evidence could better support a wide range of regulatory decisions. And while sponsors, researchers, policymakers, and regulatory agencies continue to develop real world evidence (RWE) frameworks to achieve that express aim, guiding principles are emerging related to the selection of adequate real-world data sources and appropriate study designs within specific regulatory contexts: How do specific characteristics related to disease area, data source, or analytical method affect questions around maintaining randomization? When can well-done observational studies suffice for generating actionable evidence? Are we nearing truly proof-of-concept pilot opportunities?
Learning Objective : Describe unique applications of real world evidence (RWE) to advance healthcare knowledge and decision making; Describe potential uses of RWE to improve the speed and cost effectiveness determining safety and effectiveness of medical products in real-world use.
Speaker(s)
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
Paul A. Bleicher, MD, PHD
Chief Executive Officer , Optum Labs, Inc. , United States
Pall Jonsson, PHD, MS
Programme Director - Data and RWE, National Institute for Health and Care Excellence (NICE), United Kingdom
Cathy W Critchlow, PHD, MSC
Vice President, R&D Data Strategy, Amgen, Inc, United States
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