An exact method for analysis following a two-stage phase II cancer clinical trial.

摘要: This paper presents an exact method for the analysis of a phase II cancer clinical trial conducted using two-stage design in which early stopping may be allowed either futility or efficacy. The provides point and interval estimate response probability associated with treatment under investigation p-value testing whether this exceeds some standard null value. Two-stage designs are often used trials oncology reasons ethics efficiency, but feature is seldom taken into account when results analyzed. After any multi-stage design, should take previous interim analyses performed, otherwise will biased. In paper, approximate approach based on log-odds ratio parameterisation compared through calculation precise coverage probabilities each approach.