Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective
Practical issues and lessons learned from multi-regional clinical trials via case examples: a Japanese perspective
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DOI：
10.1002/pst.448
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发表时间：
2010-07-01
影响因子：
1.5
通讯作者：
Hamasaki, Toshimitsu
中科院分区：
文献类型：
--
作者：
Ando, Yuki;Hamasaki, Toshimitsu
在全球同时开发和注册新药的过程中，在世界不同地区进行的多地区临床试验（MRCT）在为新药的疗效和安全性提供证据方面发挥着重要作用，以支持患者快速获得医疗产品。然而，就质量、设计、执行、分析和解释而言，这类审判提出了相当大的挑战。在这篇文章中，我们分享我们的观察和经验教训，从设计，实施，分析和解释一些MRCT的案例。沿着介绍了日本关于MRCT的现行监管指南，并对设计、实施和解释提出了一些建议。版权所有（C）2010约翰威利父子有限公司
The multi-regional clinical trials (MRCTs) being administered in different regions of the world now play a major role in providing evidence for the efficacy and safety of new drugs amidst the simultaneous global development and worldwide registration of such drugs, in support of the expeditious availability of medical products to patients. However, such trials present considerable challenges as far as quality, design, implementation, analysis, and interpretation are concerned. In this article, we share our observations and lessons learned from the design, implementation, analysis, and interpretation of some MRCTs with case examples. Current Japanese regulatory guidance on MRCTs is introduced along with some suggestions for design, implementation, and interpretation. Copyright (C) 2010 John Wiley & Sons, Ltd.