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InterContinental San Francisco

Nov 05, 2018 7:00 AM - Nov 06, 2018 3:00 PM

888 Howard Street, San Francisco, CA 94103

Real World Evidence Conference

This conference has reached maximum capacity.

Session 3: Use of RWE to Supplement Clinical Trial Design

Session Chair(s)

Sophie  Janssens

Sophie Janssens

Vice President, Global Head of Real World Evidence

UCB Pharma, Inc, Belgium

Mark  Stewart, PhD

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)

Jacqueline A. Corrigan-Curay, JD, MD

Use of RWE to Supplement Clinical Trial Design: Jacqueline A. Corrigan-Curay, JD, MD

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)

FDA, United States

Khaled  Sarsour, PhD, MPH

Creating External Control Arms for Clinical Trials with RWD: Issues and Implications : Khaled Sarsour, PhD, MPH

Global Head, RWD Hematology-Oncology

Genentech, A Member of the Roche Group, United States

Anuraag  Kansal, PhD

Use of RWE to bridge between endpoints for regulatory and reimbursement audiences : Anuraag Kansal, PhD

Senior Research Leader and Director

Evidera, United States

David  Thompson, PhD

Use of Real-World Data to Supplement Clinical Trial Design:Protocol Feasibility & Patient Identification : David Thompson, PhD

Founder and Principal Consultant

Rubidoux Research LLC, United States

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