Binomial Noninferiority

Program Code

The program is written in R.


Kopecky K and Green S (2012). Noninferiority trials. In: Handbook of Statistics in Clinical Oncology. Crowley J and Hoering A, eds. CRC Press, Boca Raton, FL USA.


This program calculates the required sample size for a two-arm non-inferiority design with a binomial outcome. N is calculated by the following formula for specified power = 100(1- β)% and the true success probabilities are PE and PS:

$$N = [{Z_{a/2} + Z_\beta \over M + (P_E - P_S)}]^2 \times [{P_E(1 - P_E) \over K_E} + {P_S(1 - P_S) \over 1 - K_E}]$$


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