Noninferiority testing in clinical trials : issues and challenges / Tie-Hua Ng
- 作者： Ng, Tie-Hua
- 出版： Boca Raton : Taylor & Francis/CRC Press 2015
- 叢書名： Chapman & Hall/CRC biostatistics series
- 主題： Clinical trials--Statistical methods. , Drugs--Therapeutic equivalency , Controlled Clinical Trials as Topic--methods , Data Interpretation, Statistical. , Therapeutic Equivalency
- ISBN： 9781466561496 (hbk.) :: US$78.23 、 1466561491 (hbk.)
- 一般註：Includes bibliographical references and index
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讀者標籤：
- 系統號： 005219052 | 機讀編目格式
館藏資訊
摘要註
"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
內容註
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