Noninferiority Testing in Clinical Trials: Issues and Challenges

Author:   Tie-Hua Ng
Publisher:   Taylor & Francis Inc
Volume:   68
ISBN:  

9781466561496


Pages:   208
Publication Date:   01 December 2014
Format:   Hardback
Availability:   In Print   Availability explained
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Noninferiority Testing in Clinical Trials: Issues and Challenges


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Full Product Details

Author:   Tie-Hua Ng
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Volume:   68
Dimensions:   Width: 15.60cm , Height: 1.80cm , Length: 23.40cm
Weight:   0.498kg
ISBN:  

9781466561496


ISBN 10:   1466561491
Pages:   208
Publication Date:   01 December 2014
Audience:   College/higher education ,  General/trade ,  Tertiary & Higher Education ,  General
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

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.

Reviews

The author gives interesting examples and discusses all issues critically with respect to existing literature. Furthermore, striking and convincing motivation is given as well as discussions at the ends of most chapters. Many diagrams and graphs clearly illustrate the respective content and statistical issues. The book allows readers from different fields to understand the concept of NI testing as well as issues and challenges related to NI testing. ~Biometrics, 2017 This book is intended for statisticians and non-statisticians working in the area of drug development, and it is written to be easily understood by a broad audience without any prior knowledge of non-inferiority testing. It covers important aspects of non-inferiority testing, including onesided and two-sided hypotheses, equivalence/non-inferiority margins, fixed-margin and the synthesis methods, controversial issues with switching between superiority and non-inferiority testing, tests with binary, continuous and time-to-event endpoints, multiple historical studies and meta-analysis, regulatory guidances, and issues and challenges in these tests. ~Lili Zhao, University of Michigan


The author gives interesting examples and discusses all issues critically with respect to existing literature. Furthermore, striking and convincing motivation is given as well as discussions at the ends of most chapters. Many diagrams and graphs clearly illustrate the respective content and statistical issues. The book allows readers from different fields to understand the concept of NI testing as well as issues and challenges related to NI testing. ~Biometrics, 2017


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Tie-Hua Ng

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