Seamless Phase 2 3 in Oncology

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  • เผยแพร่เมื่อ 30 ก.ย. 2024
  • This online event provides valuable insights into seamless Phase 2/3 designs in oncology.
    Among a number of possible adaptive features, common designs involve arm dropping for futility, sample size re-estimation, and population enrichment. This webinar with James Matcham, VP Statistical Strategic Consulting, Therapeutic Development Team Cytel (Australia) covers the major statistical considerations for designing and analysing seamless phase 2/3 studies in oncology, including:
    • Planning interim analyses with objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) endpoints
    • Controlling type I error in the context of interim analyses and multiple endpoints
    • The role of simulations in finalising the design
    • Regulatory experience

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