Tie-Hua Ng

Noninferiority Testing in Clinical Trials (eBook, PDF)

Issues and Challenges

• Format: PDF

Produktbeschreibung

Take Your NI Trial to the Next LevelReflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI test

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 208
• Erscheinungstermin: 1. Dezember 2014
• Englisch
• ISBN-13: 9781466561502
• Artikelnr.: 42013458

Autorenporträt

Tie-Hua Ng

Inhaltsangabe

Introduction. Choice of Noninferiority Margin for the Mean Difference.
Choice of Noninferiority Margin for the Mean Ratio and Hazard Ratio.
Noninferiority Hypotheses with Binary Endpoints. Two Statistical Approaches
for Testing the Noninferiority Hypothesis. Switching between Superiority
and Noninferiority. Multiple Historical Studies and Meta-Analysis. Three
Treatment Groups. Regulatory Guidances. Intention-to-Treat versus
Per-Protocol. Thrombolytic Example. Issues and Challenges. Index.