Tie-Hua Ng

Noninferiority Testing in Clinical Trials

Issues and Challenges

• Broschiertes Buch

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 tr

Produktdetails

• Verlag: Chapman and Hall/CRC
• Seitenzahl: 210
• Erscheinungstermin: 30. Juni 2020
• Englisch
• Abmessung: 234mm x 156mm x 12mm
• Gewicht: 327g
• ISBN-13: 9780367576028
• ISBN-10: 0367576023
• Artikelnr.: 74896271

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.