Design and Analysis of Clinical Trials: Concepts and Methodologies, 3/e (Hardcover)

Shein-Chung Chow, Jen-Pei Liu

  • 出版商: Wiley
  • 出版日期: 2013-11-18
  • 售價: $5,810
  • 貴賓價: 9.5$5,520
  • 語言: 英文
  • 頁數: 892
  • 裝訂: Hardcover
  • ISBN: 0470887656
  • ISBN-13: 9780470887653
  • 海外代購書籍(需單獨結帳)

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商品描述

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.

商品描述(中文翻譯)

第二版的讚譽:「...對於生物統計學家來說,這是一場盛宴。它隨時準備滿足任何具有可觀統計胃口的製藥科學家的需求。」-《臨床研究最佳實踐期刊》
《臨床試驗的設計與分析》第三版提供了對最近的健康治療和干預措施的完整、全面和擴展的涵蓋。本書以統一的呈現方式,提供了對當前監管要求和最近發展的統計方法的平衡總結,以及對臨床研究和開發不同階段使用的各種設計和分析的概述。第三版的其他特點包括:
- 新增了關於生物標記開發和目標臨床試驗、自適應設計、評估診斷設備的試驗、轉化醫學的統計方法以及中醫的傳統中藥的章節
- 對當前和新興臨床問題以及新開發的統計方法進行平衡的概述
- 展示日常應用性的臨床試驗實例,並通過插圖和例子解釋關鍵概念
- 新增了關於橋接研究和全球試驗、QT試驗、多國試驗、比較效果試驗以及QT/QTc延長分析的章節
- 對臨床和科學問題、統計概念以及橋接臨床和統計學科的方法進行全面平衡的呈現
- 每章的更新反映了藥物審查和批准過程的監管要求變化以及臨床研究和開發的統計設計和方法的最新發展
《臨床試驗的設計與分析》第三版繼續是學術、製藥、醫學和監管科學家/研究人員、統計學家和研究生的理想臨床研究參考資料。

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