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Session 3: Master Protocols in the COVID-19 Pandemic and Beyond
Session Chair(s)
Rebecca Hager, PHD
Mathematical Statistician, Office of Biostatistics, CDER, FDA, United States
Cindy Lu, DRSC, PHD
Director Biostatistics, Biogen, United States
Venkat Sethuraman, PHD, MBA, MS
Senior Vice President, Global Biometrics and Data Sciences, Bristol Myers Squibb, United States
This session will review current design and implementation considerations, practical challenges, regulatory landscape, and perspectives from a patient advocate group on master protocols. The considerations covered in this session applies to various therapeutic areas, though specific considerations will also be presented for COVID-19 master protocols.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the basic concept of master protocol and its applications in the COVID-19 pandemic
- Discuss the advantages of a master protocol framework and why it is popular in the recent drug development era
- Discuss some general considerations and challenges in designing and implementing the master protocol framework
Speaker(s)
Robert A. Beckman, MD
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, United States
Master Protocols: Benefits for Clinical Trial Participants and Patients
Martin Posch, PHD
Professor, Medical University of Vienna, Austria
Speaker
Gregory Levin, PHD
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Speaker
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