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Title Noninferiority testing in clinical trials : issues and challenges / Tie-Hua Ng.
Imprint Boca Raton : Taylor & Francis/CRC Press, 2015.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource.
Series Chapman & Hall/CRC biostatistics series
Chapman & Hall/CRC biostatistics series.
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Clinical trials -- Methods.
Drugs -- Therapeutic equivalency.
Controlled Clinical Trials as Topic -- methods.
Data Interpretation, Statistical.
Therapeutic Equivalency.
Genre Methods (Music)
Electronic books.
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.
Summary "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.
Other Title Print version: Ng, Tie-Hua. Noninferiority testing in clinical trials 9781466561496