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Thursday, June 18 • 5:00pm - 6:00pm
#559 OD: ON DEMAND - Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?

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Component Type: Forum
Level: Intermediate

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 Objectives

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.


David Thompson, PhD


Replication of RCTs with RWE: What Does Good Look Like?
David Thompson, PhD

Replication of RCTs with RWE: the OPERAND Project
Barbara E Bierer, MD

Replication of RCTs with RWE: Moderator Setting the Stage
Lucinda Orsini, MPH

Replication of RCTs with RWE: the RCT DUPLICATE Project
William H. Crown, PhD, MA

avatar for David Thompson

David Thompson

Senior Vice President, Real World Evidence, Syneos Health
David Thompson, Ph.D. is Senior Vice President, Real World Research for Syneos Health. Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. He is Editor-in-Chief of ISPOR’s... Read More →
avatar for Barbara Bierer

Barbara Bierer

Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School, United States
Barbara Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative... Read More →

Lucinda Orsini

Associate Chief Science Officer, ISPOR
Lucinda Orsini is currently Associate Chief Science Officer at ISPOR. The science office at ISPOR develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Lucinda has spent most of her ~20-year career in health economics and outcomes... Read More →
avatar for William Crown

William Crown

Chief Scientific Officer, Optumlabs
William H. Crown, Ph.D., is Chief Scientific Officer of OptumLabs responsible for research activities of the Labs. From 2004-2013, Dr. Crown was President of the health economics, late phase research, data products, and epidemiology business units at Optum Life Sciences. He was Vice... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum