Noninferiority Testing in Clinical Trials (eBook, PDF) - Ng, Tie-Hua
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Requiring no prior knowledge of NI testing, this book explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues with estimating the effect size based on historical placebo control trials of the active control. The author covers basic concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. He also describes patient populations, three-arm trials, and the equivalence of three or more groups.

Produktbeschreibung
Requiring no prior knowledge of NI testing, this book explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues with estimating the effect size based on historical placebo control trials of the active control. The author covers basic concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. He also describes patient populations, three-arm trials, and the equivalence of three or more groups.

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