Optimizing Phase 2 Trial Designs with Program-Level Simulations

Clinical Trial Innovations Webinar Series

Jim Bolognese, Cytel and Narinder Nangia, Alkermes revealed how Phase 2 sample size can be optimised to yield maximum eNPV when 1 or 2 doses could be selected for Phase 3. They then analyzed the study of more doses adaptively in Phase 2 toward to improve PoS and increased eNPV (unless AE rates low for all doses). 


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