Non-Inferiority Trial Sample Size Calculator

Non-Inferiority Trial Sample Size Calculator

Non-Inferiority Trial Sample Size Calculation Table

ParameterDescription
Type of StudyNon-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 EffectDifference between experimental and control groups
Standard Deviation (σ)Expected variability in outcome measures
Allocation Ratio1:1 (equal) or different (e.g., 2:1)
Statistical TestT-test, Z-test, Chi-square, or other appropriate test
Endpoint TypeBinary (proportion), Continuous (mean), or Time-to-Event
Sample Size FormulaDepends on test and endpoint type (see below)
AdjustmentsLoss to follow-up, interim analysis, multiple comparisons

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