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Sinopsis
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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Acerca del autor
Dr. Mark Rothmann earned his Ph. D. in Statistics at the University of Iowa. He taught several years as a professor and has worked at the U. S. Food and Drug Administration. He has done research in many areas involving the design and analysis of clinical trials.
Dr. Brian L. Wiens, received his MS in statistics from Colorado State University and his Ph.D. in statistics from Temple University. He has worked at several pharmaceutical, biotechnology and medical device companies since 1991. He has published research in several areas of design and analysis of clinical trials. Dr. Wiens is a Fellow of the American Statistical Association.
Dr. Ivan S.F. Chan received his M.S. in Statistics from The Chinese University of Hong Kong and his Ph.D. in Biostatistics from University of Minnesota. He has worked at Merck Research Laboratories since 1995 and is currently Senior Director and Franchise Head for vaccines, leading the statistical support for all vaccine clinical research programs at Merck. Dr. Chan has published research in many areas of statistics including exact inference, analysis of non-inferiority trials, and methodologies for clinical trials.
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Design and Analysis of Non-Inferiority Trials
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Chapman And Hall/CRC Jun 2020, 2020
ISBN 10: 0367576910
ISBN 13: 9780367576912
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Taschenbuch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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 trialsSpecific issues and analysis methods when the data are binary, continuous, and time-to-eventThe history of non-inferiority trials and the design and conduct considerations for a non-inferiority trialThe strength of evidence of an efficacy finding and how to evaluate the effect size of an active control therapyA 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. 456 pp. Englisch. Nº de ref. del artículo: 9780367576912
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Design and Analysis of Non-Inferiority Trials (Chapman & Hall/CRC Biostatistics Series)
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Design and Analysis of Non-Inferiority Trials
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Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Dr. Mark Rothmann earned his Ph. D. in Statistics at the University of Iowa. He taught several years as a professor and has worked at the U. S. Food and Drug Administration. He has done research in many areas involving the design and ana. Nº de ref. del artículo: 594590405
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Design and Analysis of Non-Inferiority Trials
Publicado por
Chapman And Hall/CRC, 2020
ISBN 10: 0367576910
ISBN 13: 9780367576912
Nuevo
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Taschenbuch. Condición: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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 trialsSpecific issues and analysis methods when the data are binary, continuous, and time-to-eventThe history of non-inferiority trials and the design and conduct considerations for a non-inferiority trialThe strength of evidence of an efficacy finding and how to evaluate the effect size of an active control therapyA 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. Nº de ref. del artículo: 9780367576912
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