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Closed Testing Procedures for Group Sequential Clinical Trials with Multiple Endpoints
Author(s) -
Tang DeiIn,
Geller Nancy L.
Publication year - 1999
Publication title -
biometrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.298
H-Index - 130
eISSN - 1541-0420
pISSN - 0006-341X
DOI - 10.1111/j.0006-341x.1999.01188.x
Subject(s) - clinical trial , early stopping , computer science , simple (philosophy) , multiple comparisons problem , clinical endpoint , medicine , medical physics , intensive care medicine , statistics , mathematics , machine learning , philosophy , epistemology , artificial neural network
Summary. A simple approach is given for conducting closed testing in clinical trials with multiple end‐points 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.