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Session 4: Synthesis of Real-World Evidence and Randomized Controlled Trials
Session Chair(s)
Amy Xia, PhD
Vice President, Center for Design and Analysis, Amgen Inc., United States
While randomized controlled trials (RCT) continue to have an established place in the realm of evidence generation, real-world evidence (RWE) has drawn increasing attention in the development of medical products. This session will review and discuss supplementing or integrating evidence from RCT with RWE in the regulatory assessment of risk and benefit of drugs. Additionally, it will delve into the design and analysis of pragmatic clinical trials (PCT), as well as the strengths, limitations, and key issues relative to PCT. Speakers and panelists will discuss opportunities and challenges with access to RWE, design of PCT, and the future of clinical trials.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe benefits and methods for integrating RWE and clinical trials such as using drug use information to improve clinical trial design, design and analysis of pragmatic trials, or re-assessing benefit-risk in user population postmarketing
- Discuss challenges and limitations in access and use of RWE
Speaker(s)
Rima Izem, PhD
Associate Director Statistical Methodology, Novartis, Switzerland
Session Co-Chair
Jesse Berlin, DRSc
Senior Vice President, Epidemiology, Johnson & Johnson, United States
Where the Sidewalk Ends: Integrating RCTs, Meta-analysis, and Observational Studies – And Not Just for Safety
Elizabeth Delong, PhD
Chair, Biostatistics and Bioinformatics, Duke University, United States
Pragmatic Trials: A Compromise Between Traditional Clinical Trials and Observational Studies
Brian Bradbury, DRSc, MA
Vice President, Center for Observational Research, Amgen, United States
Panelist (Joining Session Speakers)
David Martin, MD, MPH
Vice President, Head, PCO Center of Excellence, Novartis, United States
Panelist (Joining Session Speakers)
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