A prospective combination of phase II and phase III in drug development

SummaryIn the context of clinical trials where one of several doses or treatments is selected in a phase II study to be examined further in a phase III study, we develop a formulation for the combination of the overall information obtained from such studies, which mimics the logic followed in actual drug development. The associated distribution theory is exact under the normality assumption. Extensions to more complex situations are sketched briefly.

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