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Design and Analysis of Non-Inferiority Trials (Chapman & Hall/CRC Biostatistics Series)

By: Brian L. Wiens (Author) , Ivan S.F. Chan (Author) , Mark D. Rothmann (Author)

Manufacture on Demand

Ksh 12,150.00

Format: Paperback or Softback

ISBN-10: 0367576910

ISBN-13: 9780367576912

Collection / Series: Chapman & Hall/CRC Biostatistics Series

Collection Type: Publisher collection

Publisher: Taylor & Francis Ltd

Imprint: Chapman & Hall/CRC

Country of Manufacture: GB

Country of Publication: GB

Publication Date: Jun 30th, 2020

Publication Status: Active

Product extent: 454 Pages

Weight: 707.00 grams

Product Classification / Subject(s): Clinical trials
Epidemiology & medical statistics
Probability & statistics
Biology, life sciences
Pharmaceutical technology

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The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. 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. Using examples from real clinical tri

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.

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