Type of Study | Non-inferiority trial |
Significance Level (α) | Typically 0.05 (5%), two-sided or one-sided |
Power (1 – β) | Usually 80% or 90% (common choices) |
Margin of Non-Inferiority (Δ) | The maximum acceptable difference for non-inferiority |
Expected Treatment Effect | Difference between experimental and control groups |
Standard Deviation (σ) | Expected variability in outcome measures |
Allocation Ratio | 1:1 (equal) or different (e.g., 2:1) |
Statistical Test | T-test, Z-test, Chi-square, or other appropriate test |
Endpoint Type | Binary (proportion), Continuous (mean), or Time-to-Event |
Sample Size Formula | Depends on test and endpoint type (see below) |
Adjustments | Loss to follow-up, interim analysis, multiple comparisons |