Design and Analysis of Clinical Trials: Concepts and Methodologies

Design and Analysis of Clinical Trials: Concepts and Methodologies
ISBN-10
1118458141
ISBN-13
9781118458143
Category
Mathematics
Pages
892
Language
English
Published
2013-09-30
Publisher
John Wiley & Sons
Authors
Shein-Chung Chow, Jen-Pei Liu

Description

Praise for the Second Edition: “...a grand feast for biostatisticians. It stands readyto satisfy the appetite of any pharmaceutical scientist with arespectable statistical appetite.” —Journal of ClinicalResearch Best Practices The Third Edition of Design and Analysis of ClinicalTrials provides complete, comprehensive, and expanded coverageof recent health treatments and interventions. Featuring a unifiedpresentation, the book provides a well-balanced summary of currentregulatory requirements and recently developed statistical methodsas well as an overview of the various designs and analyses that areutilized at different stages of clinical research and development.Additional features of this Third Edition include: • New chapters on biomarker development and targetclinical trials, adaptive design, trials for evaluating diagnosticdevices, statistical methods for translational medicine, andtraditional Chinese medicine • A balanced overview of current and emerging clinicalissues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrateeveryday applicability, with illustrations and examples to explainkey concepts • New sections on bridging studies and global trials, QTstudies, multinational trials, comparative effectiveness trials,and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical andscientific issues, statistical concepts, and methodologies forbridging clinical and statistical disciplines • An update of each chapter that reflects changes inregulatory requirements for the drug review and approval processand recent developments in statistical design and methodology forclinical research and development Design and Analysis of Clinical Trials, Third Editioncontinues to be an ideal clinical research reference for academic,pharmaceutical, medical, and regulatory scientists/researchers,statisticians, and graduate-level students.

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