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Virtual

Nov 09, 2020 10:00 AM - Nov 10, 2020 3:45 PM

(US Eastern Standard Time)

Real World Evidence Conference

Session 3: Novel Randomized RWE Trial Designs to Inform Regulatory Decisions

Session Chair(s)

Jingyu (Julia)  Luan, PhD

Jingyu (Julia) Luan, PhD

Executive Regulatory Science Director, BioPharmaceuticals R&D

AstraZeneca, United States

James  Harnett, PharmD, MS

James Harnett, PharmD, MS

Executive Director, Health Economics and Outcomes Research

Regeneron Pharmaceuticals, Inc. , United States

In recent years, regulators around the world encourage the industry to explore different ways to enhance the use of RWE for demonstrating effectiveness in regulatory submissions. Adopting pragmatism into Randomized Clinical Trial (RCT) design is considered a highly promising strategy of utilizing RWE in regulatory decision-making. The recent COVID-19 pandemic has drawn increased attention to novel approaches for generating evidence and will expand our understanding of the role of novel RWE trial designs. In this session, speakers and panelists from regulatory agencies, industry, and academia will discuss the design, implementation, regulatory acceptance, opportunities and challenges of novel RWE trial designs from policy, methodological, operational, and technical perspectives. Real-case studies (Registry-based Randomized Clinical Trial) that have been accepted by multiple Health Authorities will be shared.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the basic features of novel RWE trial designs
  • Identify opportunities and challenges of novel RWE trial designs
  • Review case studies of novel RWE trial designs, e.g., Registry-based Randomized Clinical Trial (R-RCT)
  • Discuss the possible boundaries in consideration for novel RWE trial designs

Speaker(s)

Charles  Lee, MBA, MS

A Case Study of Registry-based Randomized Clinical Trial (R-RCT) for Registration Purpose

Charles Lee, MBA, MS

AstraZeneca, United States

Executive Regulatory Science Director

Frank W. Rockhold, PhD, MSc

Randomized Pragmatic Clinical Trials Utilizing RWD: Myths & Realities

Frank W. Rockhold, PhD, MSc

Duke Clinical Research Institute, Duke University Medical Center, United States

Professor of Biostatistics

Robert J. Temple, MD

Panelist

Robert J. Temple, MD

FDA, United States

Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER

Stefan  James, MD

Panelist

Stefan James, MD

Uppsala University, Sweden

Professor of Cardiology

Frank W. Rockhold, PhD, MSc

Panelist

Frank W. Rockhold, PhD, MSc

Duke Clinical Research Institute, Duke University Medical Center, United States

Professor of Biostatistics

Representative Invited

Panelist

Representative Invited

National Medical Products Administration (NMPA), China

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