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| 药物临床试验适应性设计的科学性与伦理性问题 |
| Department of Scientific Research Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China |
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| DOI： |
| 中文关键词: 药物临床试验 适应性设计 科学性 伦理性 期中分析 |
| 英文关键词:Drug clinical trial Adaptive design Scientificity Ethicality Interim analysis |
| 基金项目:重大新药创制科技重大专项（编号：2017ZX09304022） |
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| 中文摘要: |
| 摘 要近年来，适应性设计研究方案的可调整性在药物临床试验中展现出独特的优势，受到临床研究人员、药物研发企业和监督管理机构的极大关注。适应性设计可以节省药物研发时间，减少试验入组人数，节省试验费用，尽早终止无效试验，具有更高的经济、临床和伦理学价值。尽管具有多方面的优势，适应性设计在具体实施中依然存在许多潜在的科学性与伦理性问题。本文结合国内外适应性设计发展概况，对这些问题进行浅析，以期促进国内药物临床试验适应性设计的良性发展。 |
| 英文摘要: |
| ABSTRACTRecently, the adaptations of study protocols of adaptive designs have showed special advantages in drug clinical trials. Widespread interests have been increased among clinical investigators, pharmaceutical companies, and regulatory authorities. Adaptive designs using in clinical trials save time in drug development, decrease the number of people enrolled in the trials, reduce expenses and stop invalid test at early time, which have more economic, clinical and ethical values. Even though there are a lot of advantages, adaptive designs may also have many potential scientific and ethical problems in practice. In this paper, with the understanding of the development of adaptive designs at home and abroad, we simply analyzed these problems for promoting the development of domestic adaptive designs. |
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