In November 2023, as part of ACTA STInG activities, we held an online event that provided valuable insights into seamless Phase 2/3 trial 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