Closed testing procedures for group sequential clinical trials with multiple endpoints.
A simple approach is given for conducting closed testing in clinical trials with multiple endpoints in which group sequential monitoring is planned. The approach allows a flexible stopping time; the earliest and latest stopping times are described. The paradigm is applicable both to clinical trials with multiple endpoints and to the one-sided multiple comparison problem of several treatments versus a control. The approach leads to enhancements of previous methods and suggestions for new methods. An example of a respiratory disease trial with four endpoints is given.
Tang
D I
DI
Statistical Sciences and Epidemiology Division, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York, USA. tang@NKI.RFMH.ORG
Geller
N L
NL
D001699:Biometry; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D018592:Cross-Over Studies; D006801:Humans; D012140:Respiratory Tract Diseases / Q000188:drug therapy / Q000503:physiopathology; D013997:Time Factors