Sample Size Re-estimation for Two Binomial Distributions Using One Interim Analysis with No Test

Music City Center 

Sample Size Re-Estimation (SSRE) is examined for comparison of two binomial distributions in a trial that includes one interim analysis (IA) for possible SSRE. This is the only goal, so there is no hypothesis test at the IA. The procedure for SSRE uses conditional power using asymptotic normality and the impact of no hypothesis test is examined using the related procedure for SSRE with hypothesis tests at the IA for both futility and superiority. The study that motivated this research was designed for SSRE only and is presented as an example of an application of this procedure.

Sample Size Re-Estimation

Binomial Distributions 

Biopharmaceutical Section