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Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
Session Chair(s)
Mehdi Najafzadeh, PhD
Senior Director
Medidata Solutions, United States
In this session, speakers from industry, academia, and the US Food and Drug Administration (FDA) will discuss innovative use cases, experiences, and challenges of implementing linkage of traditional clinical trial data to RWD.
Learning Objective : Discuss use cases of trial linkage to RWD and the benefits for patients, decision makers and sponsors; Explain requirements and best practices in implementing trial linkage to RWD; Describe current scientific and operational challenges and strategies to overcome them; Identify areas in need of further development to support the design and execution of global hybrid pragmatic studies.
Speaker(s)
Challenges and Lessons in Linkage of RWD to Trials: An Academic Perspective
Elisabetta Patorno, DrPH, MD
Brigham and Women's Hospital; Harvard Medical School, United States
Associate Professor of Medicine
Pragmatic Approaches in Hybrid Designs: Industry Perspective
Mehmet Burcu, PhD, MS, FISPE
Merck & Co., Inc., United States
Senior Director, Epidemiology
Linkage of Trials to RWD: Evolving Landscape and Overview of US Regulatory Guidance
Marie Bradley, PhD, MPH, MPharm
FDA, United States
Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER
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