Choosing phase II endpoints and designs: evaluating the possibilities.

LeBlanc, Michael; Tangen, Catherine · Clin Cancer Res · 2012

review · Level V

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Abstract

Selecting the phase II design and endpoint to achieve the best possible chance of success for a confirmatory phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets and from mathematical models can be useful tools for evaluating statistical properties.

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