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Session 2: Case Examples with Platform and Umbrella Trial Designs
Session Chair(s)
May F Mo, MBA, MS
Associate Vice President, Biostatistics, Amgen, United States
Freda Cooner, PhD
Statistician, FDA, 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)
Amy Hoover, BSN
Senior Director Clinical Development, Eli Lilly & Company, United States
Speakers
David Gold, PhD
Director Biostatistics, Amgen, United States
Precision Platform Trials with Response Adaptive Randomization
Bo Huang, PhD
Head of Immuno-Oncology Statistics, Pfizer Global Biometrics and Data Management, United States
Complex Studies and Master Protocols: Overview and Case Studies