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Testing secondary hypotheses following sequential clinical trials
Authors:Liu A  Tan M  Boyett J M  Xiong X
Institution:Biostatistics Unit, Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC 20007, USA. Liua1@gunet.georgetown.edu
Abstract:Sequential monitoring in a clinical trial poses difficulty in hypotheses testing on secondary endpoints after the trial is terminated. The conventional likelihood-based testing procedure that ignores the sequential monitoring inflates Type I error and undermines power. In this article, we show that the power of the conventional testing procedure can be substantially improved while the Type I error is controlled. The method is illustrated with a real clinical trial.
Keywords:Brownian motion approximation  Sequential monitoring  Whitehead's model
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