ABSTRACT
This chapter describes statistical methods for addressing multiplicity issues faced in cancer clinical trials, with a focus on confirmatory phase III clinical trials. Often in such confirmatory trials, multiple inferences are made using hypothesis testing approaches. Based on such inferences, the success of the trial is judged. False positive claims play an important role in this judgment and an adequate control of the Type I error rate then becomes mandatory while making such inferences. In order to adequately control the Type I error rate in situations where multiple inferences are made at one or multiple time points, appropriate multiplicity adjustments must be performed.
