Design and Analysis of Clinical Trials: Concepts and Methodologies

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Shein-Chung Chow (Covance, Inc., Princeton, New Jersey) Jen-Pei Liu (National Cheng-Kung University, Tainan, Taiwan)

Design and Analysis of Clinical Trials

Concepts and Methodologies

Shein-Chung Chow (Covance, Inc., Princeton, New Jersey), Jen-Pei Liu (National Cheng-Kung University, Tainan, Taiwan)

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English

John Wiley & Sons Inc
25 October 2013

Clinical trials; Epidemiology & medical statistics

Series: Wiley Series in Probability and Statistics

Praise for the Second Edition:

“...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices

The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include:

• New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine

• A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies

• Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts

• New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation

• A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines

• An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development

Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

By: Shein-Chung Chow (Covance Inc. Princeton New Jersey), Jen-Pei Liu (National Cheng-Kung University, Tainan, Taiwan)
Imprint: John Wiley & Sons Inc
Country of Publication: United States
Edition: 3rd edition
Dimensions: Height: 259mm, Width: 185mm, Spine: 45mm
Weight: 1.647kg
ISBN: 9780470887653
ISBN 10: 0470887656
Series: Wiley Series in Probability and Statistics
Pages: 892
Publication Date: 25 October 2013
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

SHEIN-CHUNG CHOW, PhD, is Professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. JEN-PEI LIU, PhD, is Professor in the Department of Agronomy and Institute of Epidemiology and Preventive Medicine at the National Taiwan University. He has authored multiple articles and books on clinical trials and been involved in clinical trials as a biostatistician for more than twenty-five years.

Reviews for Design and Analysis of Clinical Trials: Concepts and Methodologies

In summary, this third edition is an impressive expansion beyond a remarkable second edition. This book would be good reference for biostatisticians, clinical researchers, and pharmaceutical scientists in clinical research and development. (Journal of Biopharmaceutical Statistics, 1 July 2014) Design and Analysis of Clinical Trials: Concepts and Methodologies, Third Edition is a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite...Essential reading for clinical research professionals. (Journal of Clinical Research Best Practice February 2014)