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Clinical Statistics for Nonstatisticians


Session 5: Analysis Plan

Session Chair(s)

Rafe  Donahue, PhD

Rafe Donahue, PhD

  • Senior Director, Biometrics
  • Sierra Oncology, United States
Important statistical considerations for constructing an analysis plan for a clinical trial will be discussed.
  • The primary question of interest
  • Primary endpoint
  • Choice of the control
  • Treatment allocation
  • Analysis groups – intent to treat or correct protocol
  • Common statistical methodology
  • Multiple endpoints and multiple comparisons
  • Interim analysis
  • Subgroup analysis
  • Examples

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