3rd Edition
by Shein-Chung Chow (Author), Jen-Pei Liu (Author)
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.