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Design and Analysis of Clinical Trials: Concepts and Methodologies

Design and Analysis of Clinical Trials: Concepts and Methodologies - Free Ebook Download

Book Detail

Author/Editor(s): Shein-Chung Chow, Jen-Pei Liu
Publication Date: November 18, 2013
ISBN-10: 0470887656
ISBN-13: 978-0470887653
Language: English
Edition: 3
Publisher: Wiley
Size: 11.0 MB
Format: pdf

Book Description

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.

About the Author

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.


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
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