title: Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.
abstract: Phase II clinical trials are often conducted to determine whether a new treatment is sufficiently promising to warrant a major controlled clinical evaluation against a standard therapy. We consider single-arm phase II clinical trials with right censored survival time responses where the ordinary one-sample logrank test is commonly used for testing the treatment efficacy. For planning such clinical trials, this paper presents two-stage designs that are optimal in the sense that the expected sample size is minimized if the new regimen has low efficacy subject to constraints of the type I and type II errors. Two-stage designs, which minimize the maximal sample size, are also determined. Optimal and minimax designs for a range of design parameters are tabulated along with examples.
authors: Department of Statistics, Yeungnam University, Gyeongsan, Gyeongbuk, 712-749, ROK.
authors: Minjung
authors: M
authors: Kwak
authors: Sin-Ho
authors: SH
authors: Jung
mesh_terms: D000465:Algorithms; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D018572:Disease-Free Survival; D006801:Humans; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome
keywords: logrank test; minimax design; optimal design; single arm trial; time to event; two-stage design