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商品詳細
Design and Analysis of Non-Inferiority Trials.
・ISBN 978-0-367-57691-2 paper GB£ 53.99
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| 著者・編者 | Rothmann, Mark D. / Wiens, Brian L. / Chan, Ivan S.F., |
|---|---|
| シリーズ | (Chapman & Hall/CRC Biostatistics Series) |
| 出版社 | (Chapman & Hall/CRC, UK) |
| 出版年月 | 2020 |
| ページ数 | 454 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-43006＞ |
解説
The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority trial. Each chapter begins with a non-technical introduction, making the text easily understood by those without prior knowledge of this type of trial.
Topics covered include:
- A variety of issues of non-inferiority trials, including multiple comparisons, missing data, analysis population, the use of safety margins, the internal consistency of non-inferiority inference, the use of surrogate endpoints, trial monitoring, and equivalence trials
- Specific issues and analysis methods when the data are binary, continuous, and time-to-event
- The history of non-inferiority trials and the design and conduct considerations for a non-inferiority trial
- The strength of evidence of an efficacy finding and how to evaluate the effect size of an active control therapy
A comprehensive discussion on the purpose and issues involved with non-inferiority trials, Design and Analysis of Non-inferiority Trials will assist current and future scientists and statisticians on the optimal design of non-inferiority trials and in assessing the quality of non-inferiority comparisons done in practice.