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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)
Speaker
Sabrina Paganoni, MD, PhD
Harvard Medical School, Healey Center for ALS at Mass General, United States
Assistant Professor
Speaker
Marianne K Chase
Neurological Clinical Research Institute, Massachusetts General Hospital, United States
Senior Director of Clinical Trial Operations
Panelist
Philip John Green
CTTI, United States
Steering Committee Patient Representative
Panelist
Sundeep Surendra Sethi, MD, MBA
AbbVie, Inc., United States
Vice President, Safety Operations
Panelist
Stephen Finger, PhD
HEALEY ALS Platform Trial Patient Advisory Committee, United States
ALS Patient Advocate
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