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Group sequential test strategies for superiority and non‐inferiority hypotheses in active controlled clinical trials
Author(s) -
Wang SueJane,
James Hung H. M.,
Tsong Yi,
Cui Lu
Publication year - 2001
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/sim.820
Subject(s) - type i and type ii errors , sample size determination , test (biology) , early stopping , treatment and control groups , statistics , computer science , medicine , mathematics , machine learning , paleontology , artificial neural network , biology
In a group sequential active controlled clinical trial, the study hypothesis may be a superiority hypothesis that an experimental treatment is more effective than the active control therapy or a non‐inferiority hypothesis that the treatment is no worse than the active control within some non‐inferiority range. When it is necessary to plan for testing the superiority and the non‐inferiority hypotheses, we propose an adaptive group sequential closed test strategy by which the sample size is planned for testing superiority and is to be increased for showing non‐inferiority given that it is deemed more plausible than superiority based on the observed sample path during the course of the trial. The proposed adaptive test strategy is valid in terms of having the type I error probability maintained at the targeted α level for both superiority and non‐inferiority. It has power advantage or sample size saving over the traditional group sequential test designed for testing either superiority only or non‐inferiority only. Copyright © 2001 John Wiley & Sons, Ltd.