Multiregional Clinical Trials for Simultaneous Global New Drug Development
暫譯: 多區域臨床試驗以同時進行全球新藥開發

Chen, Joshua, Quan, Hui

Multiregional Clinical Trials for Simultaneous Global New Drug Development
  • 出版商: CRC
  • 出版日期: 2020-12-18
  • 售價: $2,400
  • 貴賓價: 9.5 折 $2,280
  • 語言: 英文
  • 頁數: 353
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0367737221
  • ISBN-13: 9780367737221

    • 海外代購書籍(需單獨結帳)

商品描述

In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, industry, and health organizations address various aspects of the important problems in global clinical development and MRCTs.





The book first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes with an examination of the latest research topics from MRCT perspectives, such as special considerations by local health authorities, health economic evaluations, benefit-risk assessment, and medical devices.





Explaining how to design, conduct, and interpret MRCTs, this book will help biostatisticians working in the late-stage clinical development of medical products. It will also be useful for statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.

商品描述(中文翻譯)

在全球臨床開發策略中，多區域臨床試驗（MRCTs）對於創新藥物的開發至關重要。《多區域臨床試驗以同時進行全球新藥開發》提供了有關在臨床開發中進行 MRCTs 的當前狀況的全面概述。來自學術界、產業界和健康組織的國際專家探討了全球臨床開發和 MRCTs 中重要問題的各個方面。

本書首先對使用 MRCTs 進行同時全球臨床開發的背景、動機、機會和挑戰進行高層次的介紹。接著，重點關注 MRCTs 的設計、監測和分析/解釋。本書最後檢視了從 MRCT 角度出發的最新研究主題，例如當地衛生當局的特殊考量、健康經濟評估、效益風險評估以及醫療設備。

本書解釋了如何設計、執行和解釋 MRCTs，將幫助在醫療產品晚期臨床開發中工作的生物統計學家。對於生物製藥產業、監管機構和醫學研究機構中的統計學家和臨床醫生也將非常有用。

作者簡介

Joshua Chen is the global head of biostatistics and programming at Sanofi Pasteur. He previously worked on clinical development of small molecules, biologics, and vaccines at Merck Research Laboratories. His experience spans many therapeutic areas with a major focus on human vaccines and antiviral drugs. He has extensive experience in the study, design, conducting, and reporting of international clinical trials from proof of concept through regulatory approvals and life cycle management. His primary research interest is clinical trial designs, including group sequential methods, adaptive designs, and multiregional clinical trials (MRCTs). Dr. Chen was a colead of the cross-industry MRCT Consistency Working Group under PhRMA (2008-2011) and the Society for Clinical Trials (2012-2014). He earned his PhD in statistics from the University of Wisconsin-Madison.



Hui Quan is an associate vice president and global head of the methodology group in the Biostatistics and Programming Department of Sanofi-Aventis. A fellow of the American Statistical Association, he has 24 years of pharmaceutical industry experience in many therapeutic areas ranging from early phase to phase IV studies. He has published 82 papers, including 59 statistical papers. His research interests include multivariate analysis, safety analysis, multiplicity adjustment, missing handling, adaptive design, integrated data analysis, modeling and simulation, benefit/risk assessment, and MRCTs. Dr. Quan was a colead of the MRCT Consistency Assessment Working Group under PhRMA (2008-2011) and the Society for Clinical Trials (2012-2014). He earned his PhD in statistics from Columbia University.

作者簡介(中文翻譯)

陳家豪是賽諾菲巴斯德的全球生物統計與程式設計負責人。他之前在默克研究實驗室從事小分子、生物製劑和疫苗的臨床開發。他的經驗涵蓋多個治療領域，主要專注於人類疫苗和抗病毒藥物。他在國際臨床試驗的研究、設計、執行和報告方面擁有豐富的經驗，從概念驗證到監管批准及生命週期管理。他的主要研究興趣是臨床試驗設計，包括群組序列方法、適應性設計和多區域臨床試驗（MRCTs）。陳博士曾擔任PhRMA（2008-2011）和臨床試驗學會（2012-2014）跨行業MRCT一致性工作組的共同負責人。他在威斯康辛大學麥迪遜分校獲得統計學博士學位。

權輝是賽諾菲-安萬特生物統計與程式設計部門的方法學組的副總裁及全球負責人。他是美國統計學會的研究員，擁有24年的製藥行業經驗，涵蓋從早期階段到第四期研究的多個治療領域。他已發表82篇論文，其中包括59篇統計學論文。他的研究興趣包括多變量分析、安全性分析、多重調整、缺失處理、適應性設計、整合數據分析、建模與模擬、效益/風險評估以及MRCTs。權博士曾擔任PhRMA（2008-2011）和臨床試驗學會（2012-2014）MRCT一致性評估工作組的共同負責人。他在哥倫比亞大學獲得統計學博士學位。

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