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)
DIAN-TU Platform Trial: Lessons Learned *this presentation will only be available live and not on demand
Charles F. and Joanne Knight Distinguished Professor of Neurology , Washington University School of Medicine, United States
DIAN Platform Trial: Statistical Design
President and Senior Statistical Scientist, Berry Consultants LLC, United States
DIAN-TU Platform: Operational Complexities and Considerations
Senior Director, Clinical Operations, Washington University School of Medicine, DIAN Trials Unit, United States
IQVIA Perspective
CNS Project Management, IQVIA, United States
Perspective from Lilly
Global Head, External Engagement, Alzheimer's Disease and Neurodegeneration, Eli Lilly and Company, United States
Perspective from Roche
Global Development Leader, F. Hoffmann-La Roche, Ltd., Switzerland
Speaker
Executive Director, Cancer Medicine Research, UT MD Anderson Cancer Center , United States
Statistical Aspects of the ROAR Basket Trial
Director of Research. Senior Statistical Scientist, Berry Consultants, United States
Have an account?