Chapman & Hall/Crc Biostatistics Series- Design And Analysis Of Non-Inferiority Trials

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Brings together a body of research and discusses the issues involved in the design of a non-inferiority trial. This book uses examples from real clinical trials, and discusses general and regulatory issues and illustrates how they affect analysis. It also provides mathematical approaches along with their mathematical properties.

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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Chapman & Hall/Crc Biostatistics Series- Design And Analysis Of Non-Inferiority Trials

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