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ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?
Session Chair(s)
David Thompson, PhD
Founder and Principal Consultant
Rubidoux Research LLC, United States
This forum will explore issues in the use of real world evidence for regulatory purposes, focusing on attempts to replicate results from randomized controlled trials (RCTs) with analyses of real world data (RWD). It will describe two ongoing RCT replication efforts: the RCT DUPLICATE project and the OPERAND project. Issues related to the interpretation of findings will be highlighted and discussed.
Learning Objective : Discuss the key methodologic issues in using real world data (RWD) to replicate random controlled trials (RCTs); Assess discrepancies between findings from RCTs and real world studies; Evaluate the implications of current efforts to replicate RCTs using analyses of RWD sources.
Speaker(s)
Replication of RCTs with RWE: What Does Good Look Like?
David Thompson, PhD
Rubidoux Research LLC, United States
Founder and Principal Consultant
Replication of RCTs with RWE: the OPERAND Project
Barbara E Bierer, MD
Harvard Medical School, United States
Faculty Director, MRCT Center; Professor of Medicine
Replication of RCTs with RWE: Moderator Setting the Stage
Lucinda Orsini, MPH
COMPASS Pathways, United States
Vice President - Value and Outcomes Research
Replication of RCTs with RWE: the RCT DUPLICATE Project
William H. Crown, PhD, MA
Brandeis University , United States
Distinguished Research Scientist, Heller School for Social Policy and Management
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