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Session 3: Lessons Learned from Ongoing Master Protocol Platform Trial
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 present lessons learned from a newly initiated Master Protocol Trial regarding strategy and design choice, operational challenges and disclosure considerations, and the role of patients and advocacy groups in the platform trial development. This session will feature the experiences from the newly initiated HEALEY ALS (Amyotrophic Lateral Sclerosis) Platform Trial.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the rationale for choosing a Master Protocol Platform Trial design and key design features
- Identify the unique operational challenges and disclosure considerations required for implementing a Master Protocol Platform Trial
- Summarize the role of patient and advocacy groups and perspective towards Master Protocol Platform Trials
Speaker(s)
Sabrina Paganoni, MD, PHD
Assistant Professor, Harvard Medical School, Healey Center for ALS at Mass General, United States
Speaker
Marianne K Chase
Senior Director of Clinical Trial Operations, Neurological Clinical Research Institute, Massachusetts General Hospital, United States
Speaker
Philip John Green
Steering Committee Patient Representative, CTTI, United States
Panelist
Sundeep Surendra Sethi, MD, MBA
Vice President, Safety Operations, AbbVie, Inc., United States
Panelist
Stephen Finger, PHD
ALS Patient Advocate, HEALEY ALS Platform Trial Patient Advisory Committee, United States
Panelist
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