Testing secondary hypotheses following sequential clinical trials |
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Authors: | Liu A Tan M Boyett J M Xiong X |
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Institution: | Biostatistics Unit, Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC 20007, USA. Liua1@gunet.georgetown.edu |
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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. |
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Keywords: | Brownian motion approximation Sequential monitoring Whitehead's model |
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