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.
General
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