title: Sample size computation for two-sample noninferiority log-rank test.
abstract: When an experimental therapy is less extensive, less toxic, or less expensive than a standard therapy, we may want to prove that the former is not worse than the latter through a noninferiority trial. In this article, we discuss a modification of the log-rank test for noninferiority trials with survival endpoint and propose a sample size formula that can be used in designing such trials. Performance of our sample size formula is investigated through simulations. Our formula is applied to design a real clinical trial.
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA. jung0005@mc.duke.edu
authors.forename: Sin-Ho
authors.initials: SH
authors.lastname: Jung
authors.forename: Sun J
authors.initials: SJ
authors.lastname: Kang
authors.forename: Linda M
authors.initials: LM
authors.lastname: McCall
authors.forename: Brent
authors.initials: B
authors.lastname: Blumenstein
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D015233:Models, Statistical; D018401:Sample Size