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Session 5: Analysis Plan
Session Chair(s)
Rafe Donahue, PhD
Chief Statistical Advisor
Bufnagle Consulting, 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