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Session 2: CID - Master Protocols
Session Chair(s)
Zoran Antonijevic, MSC
Vice President, Statistical Consulting, Abond CRO Inc., United States
Min Lin, MD, PHD
Statistical Science Director, Astrazeneca, United States
Rui (Sammi) Tang
Vice President, Global Head of Biometrics, Servier Pharmaceuticals, United States
Master Protocols test multiple therapies in one indication, one therapy for multiple indications, or both. They also allow for discontinuation or addition of treatment arms and the concept known as platform trial. Master Protocols can significantly improve the efficiency of drug development when appropriately designed and implemented. In this session we will discuss how to manage Master Protocols design and implementation complexities. We will present one case study and then follow-up with novel approaches that focus on the confirmatory stage of development.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand essential elements of Master Protocols
- Recognize opportunities for application of Mater Protocols
- Understand and apply new approaches and trends in design of Master Protocols
Speaker(s)
James Travis, PHD
Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Speaker
Michael Proschan, PHD
Mathematical Statistician, NIAID/NIH, United States
Design and Analysis of Treatment Trials of Ebola Virus Disease
Lisa LaVange, PHD
Professor Emerita, University of North Carolina at Chapel Hill, United States
Speaker
Vladimir Dragalin, PHD
Vice President, Scientific Fellow, Janssen R&D, at Johnson & Johnson, United States
Complex Innovative Design for a Basket Trial
Nora E Carbine
Georgetown Breast Cancer Advocate, Georgetown Lombardi Cancer Center , United States
Panelist