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Modification of Sample Size in Group Sequential Clinical Trials
Author(s) -
Cui Lu,
Hung H. M. James,
Wang SueJane
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.1999.00853.x
Subject(s) - sample size determination , group (periodic table) , sample (material) , clinical trial , statistics , computer science , mathematics , medicine , chemistry , chromatography , organic chemistry
Summary. In group sequential clinical trials, sample size reestimation can be a complicated issue when it allows for change of sample size to be influenced by an observed sample path. Our simulation studies show that increasing sample size based on an interim estimate of the treatment difference can substantially inflate the probability of type I error in most practical situations. A new group sequential test procedure is developed by modifying the weights used in the traditional repeated significance two‐sample mean test. The new test has the type I error probability preserved at the target level and can provide a substantial gain in power with the increase of sample size. Generalization of the new procedure is discussed.