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Full Description
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.
Contents
What Is a Non-Inferiority Trial? Non-Inferiority Trial. Considerations. Strength of Evidence and Reproducibility. Evaluating the Active Control Effect. Across-Trials Analysis Methods. Three-Arm Non-Inferiority Trials. Multiple Comparisons. Missing Data and Analysis Sets. Safety Studies. Additional Topics. Inference on Proportions. Inferences on Means and Medians. Inference on Time-to-Event End Points. Appendix: Statistical Concepts. Index.
