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Group Sequential Methods for Clinical Trials with a One-Sided Hypothesis
David L. Demets and James H. Ware
Vol. 67, No. 3 (Dec., 1980), pp. 651-660
Stable URL: http://www.jstor.org/stable/2335135
Page Count: 10
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Pocock (1977) has recently proposed group sequential methods for sequential analysis of clinical trials. However, these methods are intended to test a null hypothesis against a two-sided alternative, and many trials of a new therapy against a standard have one-sided alternatives. Continuation of the trial to determine whether the new therapy is actually inferior to the standard therapy may be inappropriate or even unethical. In the present paper, three possible modifications of the group sequential method for sequential monitoring of clinical trials testing a one-sided hypothesis are considered.
Biometrika © 1980 Biometrika Trust