Design and Analysis of Clinical Trials / Wiley Series in Probability and Statistics (PDF)

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.