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. . Language: English