Back to Agenda
Session 2: Lessons Learned from Completed and Ongoing Master Protocols
Session Chair(s)
Michelle A Detry, PHD
Director, Adaptive Trial Execution & Senior Statistical Scientist, Berry Consultants, LLC, United States
AnnCatherine M. Downing, PHARMD
Chief Operating Officer - Lilly Research Laboratories, Eli Lilly and Company, United States
This session will highlight lessons learned from multiple stakeholders across design, implementation, and data readout for a consortia-driven platform study. An ongoing, single-pharma sponsor basket trial will highlight lessons learned in building a business case, operational challenges, and planning for dissemination of results.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain key considerations for master protocols across the lifecycle of the protocol
- Articulate differences between consortia-driven and single-sponsor master protocols
- Relate multiple stakeholder perspectives within different master protocol structures
Speaker(s)
Randall J. Bateman, MD
Charles F. and Joanne Knight Distinguished Professor of Neurology , Washington University School of Medicine, United States
DIAN-TU Platform Trial: Lessons Learned *this presentation will only be available live and not on demand
Scott Berry, PHD
President and Senior Statistical Scientist, Berry Consultants LLC, United States
DIAN Platform Trial: Statistical Design
Susan Mills
Senior Director, Clinical Operations, Washington University School of Medicine, DIAN Trials Unit, United States
DIAN-TU Platform: Operational Complexities and Considerations
Tina Gislimberti, MA
CNS Project Management, IQVIA, United States
IQVIA Perspective
Phyllis Barkman Ferrell, MBA
Global Head, External Engagement, Alzheimer's Disease and Neurodegeneration, Eli Lilly and Company, United States
Perspective from Lilly
Geoffrey Kerchner, MD, PHD
Global Development Leader, F. Hoffmann-La Roche, Ltd., Switzerland
Perspective from Roche
Vivek Subbiah, MD
Executive Director, Cancer Medicine Research, UT MD Anderson Cancer Center , United States
Speaker
Kert Viele, PHD
Director of Research. Senior Statistical Scientist, Berry Consultants, United States
Statistical Aspects of the ROAR Basket Trial
Have an account?