BSWG KOL Lecture Series, L19

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Speaker: Dr Ram Tiwari (FDA)

Title: Leveraging External Evidence in Medical Device Decision-Making

Abstract: The focus of this presentation is on external evidence methods (EEM) framework for leveraging data from sources outside of prospectively designed study, referred to as external data. There is a large variety of data sources from which external data can be extracted, including RWD sources, historical clinical data, and data from modeling and simulation. We discuss statistical methods that can be used to leverage external data, with special focus on propensity-score integrated power prior and composite likelihood methods. Several examples of approved submissions where external data have been used, and an illustrative example for leveraging external evidence will be presented.

Biography: Ram C. Tiwari, Ph.D. is the Director for Division of Biostatistics, CDRH, since 2016. He joined FDA in April 2008 as Associate Director for Statistical Science and Policy in the Immediate Office, Office of Biostatistics, CDER. Prior to joining FDA, he served as Program Director and Mathematical Statistician in the Division of Cancer Control and Population Sciences at National Cancer Institute, NIH; and as Professor and Chair, Department of Mathematics, University of North Carolina at Charlotte.
Dr. Tiwari received his MS and PhD degrees from Florida State University in Mathematical Statistics. He is a Fellow of the American Statistical Association and a past President of the International Indian Statistical Association.

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