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Session 3: Use of RWE to Supplement Clinical Trial Design
Session Chair(s)
Sophie Janssens
Vice President, Global Head of Real World Evidence
UCB Pharma, Inc, Belgium
Mark Stewart, PhD
Vice President, Science Policy
Friends of Cancer Research, United States
The objective of this session is to understand how RWE has a major role to play in clinical trial design. This session will be divided into the main trials components where RWE can help decision-making: inclusion criteria, comparator (including historical and synthetic arm), endpoints, and estimating effect size. We will address the general concepts, case studies, and provide a regulatory/payer perspective.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain how RWE can facilitate clinical trial design
- Apply learning on how to improve clinical trial design while learning from the case studies
- Discuss how RWE endpoints facilitated clinical trial development and contribute to regulator/payer decision-making
Speaker(s)
Use of RWE to Supplement Clinical Trial Design
Jacqueline A. Corrigan-Curay, JD, MD
FDA, United States
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
Creating External Control Arms for Clinical Trials with RWD: Issues and Implications
Khaled Sarsour, PhD, MPH
Genentech, A Member of the Roche Group, United States
Global Head, RWD Hematology-Oncology
Use of RWE to bridge between endpoints for regulatory and reimbursement audiences
Anuraag Kansal, PhD
Evidera, United States
Senior Research Leader and Director
Use of Real-World Data to Supplement Clinical Trial Design:Protocol Feasibility & Patient Identification
David Thompson, PhD
Rubidoux Research LLC, United States
Founder and Principal Consultant