Confidence Limits for Probability of Response in Multistage Phase II Clinical Trials

Abstract

Herson (1979, Biometrics 35, 775-783) has given a method for designing one-arm k-stage phase II clinical trials, which permits early termination of the trial if the treatment is apparently ineffective, while retaining acceptable levels of power and significance. This paper gives a method for calculating the confidence limits on the response proportion, conditional on a particular study design.