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Session 2: Case Examples with Platform and Umbrella Trial Designs
Session Chair(s)
May F Mo, MBA, MS
Executive Director, Biostatistics
Amgen, United States
Freda Cooner, PhD
Senior Director - Statistics
Eli Lilly and Company, United States
Daniel Millar, MBA
Senior Director, Strategic Business Transformation
Johnson & Johnson, United States
Therapeutic areas have multiple new therapies that could potentially be efficacious in patients with the same disease type but having different biomarkers. Platform and umbrella trial designs have established efficiency in identifying efficacious treatment options and ultimately deliver these options to patients much quicker than traditional trial designs. These designs often engage multiple drug manufacturers and patient communities, which may introduce new challenges in both trial conduct and data analyses. This session will discuss the pros and cons of these designs through case studies with guidance and lessons learned.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the advantages and disadvantages of platform and umbrella trial designs
- Assess the feasibility of implementing platform and umbrella trial designs in future clinical trials
- Discuss operational considerations of platform and umbrella trials
Speaker(s)
Speakers
Amy Hoover, BSN
Eli Lilly & Company, United States
Senior Director Clinical Development
Precision Platform Trials with Response Adaptive Randomization
David Gold, PhD
Amgen, United States
Director Biostatistics
Complex Studies and Master Protocols: Overview and Case Studies
Bo Huang, PhD
Pfizer Global Biometrics and Data Management, United States
Head of Immuno-Oncology Statistics
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