Design and Analysis of Non-Inferiority Trials: 43 (Chapman & Hall/CRC Biostatistics Series) - Tapa dura

Libro 65 de 155: Chapman & Hall/CRC Biostatistics

Rothmann, Mark D.; Wiens, Brian L.; Chan, Ivan S.F.

 
9781584888048: Design and Analysis of Non-Inferiority Trials: 43 (Chapman & Hall/CRC Biostatistics Series)
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ISBN 10: 1584888040 ISBN 13: 9781584888048
Editorial: Chapman and Hall/CRC, 2011

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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Editorial
Chapman and Hall/CRC
Año de publicación
2011
Idioma
Inglés
ISBN 10 
1584888040
ISBN 13 
9781584888048
Encuadernación
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Número de edición
1
Número de páginas
454
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania

Otras ediciones populares con el mismo título

9780367576912: Design and Analysis of Non-Inferiority Trials (Chapman & Hall/CRC Biostatistics Series)

Edición Destacada

ISBN 10:  0367576910 ISBN 13:  9780367576912
Editorial: Routledge, 2020
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