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Design and Analysis of Non-Inferiority Trials
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Design and Analysis of Non-Inferiority Trials

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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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.

Produktdetaljer
Sprog: Engelsk
Sider: 454
ISBN-13: 9780367576912
Indbinding: Paperback
Udgave:
ISBN-10: 0367576910
Udg. Dato: 30 jun 2020
Længde: 0mm
Bredde: 234mm
Højde: 156mm
Oplagsdato: 30 jun 2020
Forfatter(e) Mark D. Rothmann, Brian L. Wiens, Ivan S.F. Chan


Kategori Biologi og biovidenskab


Sprog Engelsk


Indbinding Paperback


Sider 454


Udgave


Længde 0mm


Bredde 234mm


Højde 156mm

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