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Session 6: Master Protocols: Design Considerations and Operational Examples (Case-Studies)
Session Chair(s)
Jonathan Haddad, MPH
HIV Disease Area Head, Clinical Statistics, GlaxoSmithKline, United States
Min Lin, MD, PhD
Statistical Science Director, Astrazeneca, United States
Amy Xia, PhD
Vice President, Center for Design and Analysis, Amgen Inc., United States
This session will explore the design considerations and operational challenges for Master Protocols. A brief presentation of the key challenges and opportunities will be followed by a review of one or more case-studies. A multi-disciplinary panel will then discuss the statistical and operational aspects that contribute to the success (or failure) of Master Protocols.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the most common designs using Master Protocols and their utility in solving clinical development challenges
- Understand the operational challenges and considerations in executing Master Protocols
- Gain awareness to the pros, cons, and common mistakes for Master Protocol designs through a panel discussion
Speaker(s)
Scott Berry, PhD
President and Senior Statistical Scientist, Berry Consultants LLC, United States
A Brief Overview
Melissa Paoloni
VP, Medical Affairs & Clinical Partnerships, Arcus Bioscience, United States
Speaker
Sofia Paul, PhD
Senior Director, GSK, United States
Master Protocols: Design Considerations and Operational Examples (Case-Studies)
Shenghui Tang
Team leader, Division of Biometrics V of the Office of Biostatistics,CDER, FDA, United States
Panelist
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