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Group sequential designs for cure rate models with early stopping in favour of the null hypothesis
Author(s) -
Patricia Bernardo M.V.,
Ibrahim Joseph G.
Publication year - 2000
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/1097-0258(20001130)19:22<3023::aid-sim638>3.0.co;2-x
Subject(s) - null hypothesis , early stopping , statistics , confidence interval , sample size determination , mathematics , statistic , alternative hypothesis , cure rate , test statistic , econometrics , null distribution
Ewell and Ibrahim derived the large sample distribution of the logrank statistic under general local alternatives. Their asymptotic results enable us to extend several group sequential designs which allow for early stopping in favour of the null hypothesis to the setting in which the cure rate model is appropriate. In particular, we derive stopping rules for the cure rate model using conditional power, predictive power and repeated confidence intervals methods. We illustrate the methods proposed using a hypothetical phase III clinical trial which is typical for melanoma studies. Copyright © 2000 John Wiley & Sons, Ltd.