Non-inferiority and Equivalence Studies Calculator
TRUST Research Center — Evidence-based tools for clinical research
Non-inferiority Calculator
Outcome type: Proportion
◆ Outcome type & non-inferiority margin
What type of outcome is being measured?
Please select the outcome type above to determine the required sign of the margin.
■ Classic treatment
⚠ Must be between 0 and 1.
OR — enter raw counts instead
■ New treatment
⚠ Must be between 0 and 1.
OR — enter raw counts instead
Results
Mean difference (New − Classic)
—
Std. error of difference (Sed)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.NIF marginZero
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.NIF marginZero
—
—
Equivalence Calculator
Outcome type: Proportion
↔ Equivalence limit
⚠ The equivalence limit cannot be zero.
The test will use limits: — (lower) and — (upper)
Enter any non-zero value. The calculator automatically creates symmetric limits using the absolute value: −|δ| (lower) and +|δ| (upper). Equivalence is declared when the entire CI falls within these limits.
■ Classic treatment
⚠ Must be between 0 and 1.
OR — enter raw counts instead
■ New treatment
⚠ Must be between 0 and 1.
OR — enter raw counts instead
Results
Mean difference (New − Classic)
—
Std. error of difference (Sed)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.EQ limitsZero
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.EQ limitsZero
—
—
Non-inferiority Calculator
Outcome type: Risk Ratio
◆ Outcome type & non-inferiority margin (Risk Ratio)
What type of outcome is being measured?
Please select the outcome type above to determine the required value of the margin.
■ Classic treatment
■ New treatment
Results
Risk Ratio (New / Classic)
—
Se(log RR)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeRR point est.NIF marginRR=1
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeRR point est.NIF marginRR=1
—
—
Equivalence Calculator
Outcome type: Risk Ratio
↔ Equivalence limit (Risk Ratio)
⚠ Must be a positive ratio and cannot be exactly 1.
The test will use limits: — (lower) and — (upper)
Enter any positive ratio other than 1. If you enter a value above 1 (e.g. 1.25), the lower limit is set as its inverse (0.80). If you enter a value below 1 (e.g. 0.80), the upper limit is set as its inverse (1.25). Equivalence is declared when the entire CI falls within these limits.
■ Classic treatment
■ New treatment
Results
Risk Ratio (New / Classic)
—
Se(log RR)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeRR point est.EQ limitsRR=1
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeRR point est.EQ limitsRR=1
—
—
Non-inferiority Calculator
Outcome type: Quantitative (Continuous)
◆ Outcome direction & non-inferiority margin
When the outcome increases, the patient gets…
Please select the outcome direction above.
■ Classic treatment
■ New treatment
Results
Mean difference (New − Classic)
—
Std. error of difference (Sed)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.NIF marginZero
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.NIF marginZero
—
—
Equivalence Calculator
Outcome type: Quantitative (Continuous)
↔ Equivalence limit
⚠ The equivalence limit cannot be zero.
The test will use limits: — (lower) and — (upper)
Enter any non-zero value. Symmetric limits −|δ| and +|δ| are generated automatically. Equivalence is declared when the entire CI falls within these limits.
■ Classic treatment
■ New treatment
Results
Mean difference (New − Classic)
—
Std. error of difference (Sed)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.EQ limitsZero
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeMean diff.EQ limitsZero
—
—
Non-inferiority Calculator
Outcome type: Odds Ratio
◆ Outcome type & non-inferiority margin (Odds Ratio)
What type of outcome is being measured?
Please select the outcome type above to determine the required value of the margin.
■ Classic treatment
■ New treatment
Results
Odds Ratio (New / Classic)
—
Se(log OR)
—
Bilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeOR point est.NIF marginOR=1
—
—
Unilateral 95% Confidence Interval
Lower bound
—
Upper bound
—
CI rangeOR point est.NIF marginOR=1
—
—
Equivalence Calculator
Outcome type: Odds Ratio
↔ Equivalence limit (Odds Ratio)
⚠ Must be a positive ratio and cannot be exactly 1.
The test will use limits: — (lower) and — (upper)
Enter any positive ratio other than 1. If you enter above 1 (e.g. 1.25), the lower limit is its inverse (0.80). If below 1 (e.g. 0.80), the upper limit is its inverse (1.25).
Christensen, E. (2007). Methodology of superiority vs. equivalence trials and non-inferiority trials. Journal of hepatology, 46(5), 947–954.
Head, S. J., Kaul, S., Bogers, A. J., & Kappetein, A. P. (2012). Non-inferiority study design: lessons to be learned from cardiovascular trials. European heart journal, 33(11), 1318–1324.
Walker, J. (2019). Non-inferiority statistics and equivalence studies. BJA education, 19(8), 267–271.
Stefanos, R., Graziella, D. A., & Giovanni, T. (2020). Methodological aspects of superiority, equivalence, and non-inferiority trials. Internal and Emergency Medicine, 15(6), 1085–1091.
Hassouna, A. (2023). Statistics for Clinicians: How Much Should a Doctor Know? Springer Nature.