Title:
Noninferiority testing in clinical trials : issues and challenges
Author:
Ng, Tie-Hua, author.
ISBN:
9780429071140
Physical Description:
1 online resource
Series:
Chapman & Hall/CRC biostatistics series
Chapman & Hall/CRC biostatistics series (Unnumbered)
Contents:
1. Introduction -- 2. Choice of noninferiority margin for the mean difference -- 3. Choice of noninferiority margin for the mean ratio and hazard ratio -- 4. Noninferiority Hypotheses with Binary Endpoints -- 5. Two statistical approaches for testing the noninferiority hypothesis -- 6. Switching between superiority and noninferiority -- 7. Multiple historical studies and meta-analysis -- 8. Three treatment groups -- 9. Regulatory guidances -- 10. Intention-to-treat versus per-protocol -- 11. Thrombolytic example -- 12. Issues and challenges.
Abstract:
This book focuses on the rationale of choosing the noninferiority (NI) margin as a small fraction of the therapeutic effect of the active control in a clinical trial. It discusses issues of estimating the effect size based on historical placebo control trials of the active control. The book also covers basic concepts related to NI trials, such as essay sensitivity, constancy assumption, discounting, and preservation. Other topics described include patient populations, three-arm trials, and testing equivalence of three or more groups--Provided by publisher.
Subject Term:
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Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 545633-1001 | R853 .C55 N48 2015 | Searching... | Searching... |