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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