| 临床试验进展: 适应性设计及透明性 |
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| 引用本文： | 汤森路透.临床试验进展: 适应性设计及透明性[J].微生物学杂志,2014,38(5). |
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| 作者姓名： | 汤森路透 |
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| 摘 要： | 临床试验中的适应性设计是根据累积信息来修正试验的一种设计方法，旨在使临床试验和临床开发计划效率更高，并为患者提供更加有效的治疗。此外，因信息隐匿造成试验失败和患者死亡，从而导致公众对医药行业的信任度下降，故关于公开临床数据的观点已开始朝着提升透明度方向调整。介绍3 类适应性设计方法的特点和应用，以及国外药政部门和制药企业对提高临床试验透明性的举措。
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| 关 键 词： | 临床试验 适应性设计 透明性 |
Developments in Clinical Trials:Adaptive Designs and Transparancy |
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| Thomson Reuters.Developments in Clinical Trials:Adaptive Designs and Transparancy[J].Journal of Microbiology,2014,38(5). |
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| Authors: | Thomson Reuters |
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| Affiliation: | Thomson Reuters |
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| Abstract: | Adaptive designs in clinical trials incorporate trial modifications based on accumulating information, aiming at more efficient clinical trials and clinical development programs, as well as more effective treatments for patients.Moreover,as trust in the industry declines due to trial failures and patient deaths because of concealed information,views on clinical data disclosure are beginning to align in favor of increased transparency. This arcticle introduces the features of three types of adapative designs and applications in clinical trials ,as well as the measures to increase clinical trial transparency taken by the organizations of foreign drug administration and pharmaceutical industry. |
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| Keywords: | clinical trial adaptive design transparancy |
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