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Abstract

A primary objective of a phase II trial is to determine future development is warranted for a new treatment based on whether it has sufficient activity against a specified type of tumor. Limitations exist in the commonly-used hypothesis setting and the standard test procedure for a phase II trial. This study reformats the hypothesis setting to mirror the clinical decision process in practice. Under the proposed hypothesis setting, the critical points and the minimum required sample size for a desired power of finding a superior treatment at a given α -level are presented. An example is provided to illustrate how the power of finding a superior treatment by accounting for a secondary endpoint may be improved without inflating the given Type I error.

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