Sample size computation for two-sample noninferiority log-rank test.
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.
Jung
Sin-Ho
SH
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA. jung0005@mc.duke.edu
Kang
Sun J
SJ
McCall
Linda M
LM
Blumenstein
Brent
B
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D015233:Models, Statistical; D018401:Sample Size