Efficacy endpoint selection and multiplicity adjustment methods in clinical trials with inherent multiple endpoint issues

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Abstract
The ideal approach for the design and analysis of clinical trials is to select a single primary endpoint that provides a complete characterization of the disease under study and permits an efficient evaluation of the effect of a test drug. However, this is often not possible for a number of diseases or clinical trials. This paper examines some practical clinical decision‐making scenarios for the selection and analysis of efficacy outcome measures in clinical trials with inherent multiplicity components. Copyright © 2003 John Wiley & Sons, Ltd.