| 摘要: |
| 研究单位的选择是药品上市后临床试验质量控制的重要内容.研究单位选择的失败将会导致临床试验面临诸多风险,包括:研究单位不合理布局的风险、药品管理混乱的风险、募集数量不达标的风险、研究单位调整的风险、研究单位人员调整的风险、研究单位人员价值取向的风险、医疗纠纷等.根据目前国际上市后药物临床试验的开展现状,结合国内实际情况,针对药物上市后临床再研究中的问题作一探讨,以期为未来研究提供方法学参考. |
| 关键词: 单位选择 药物上市 临床试验 |
| DOI：10.11656/j.issn.1672-1519.2013.10.04 |
| 分类号: |
| 基金项目:国家青年科学基金项目(81202849);国家"重大新药创制"科技重大专项(2008ZX09312-001);教育部新世纪优秀人才计划(NCET-09-0900);天津市高等学校科技发展基金计划(20110202). |
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| Selecting strategy for test unit in re-clinical research of post-marketing drug |
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CAO Hong-bo1,2, SHANG Hong-cai1,2
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1.Institute of Traditional Chinese Medicine, Tianjin University of TCM, Tianjin 300193, China;2.Tianjin Institute of Clinical Evaluation, Tianjin 300193, China
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| Abstract: |
| The selection of study unit is an important thing for the quality control in clinical trials of post-marketing drug. Improper selection for the trial unit will result in various risks for the clinical investigation, including unbalanced distribution of these units;poor management of the drugs;recruitment number does not meet the standard;the enrolled units must be regulated;the staffs working in the unit must be regulated, varied economic requirement of the trial staffs as well as the medical disputes, etc.. In this paper, we pursued this issue by learning the experiences of international clinical trial management of post-marketing drugs, and discussed improvements that can be made in the conduct of clinical trials in China, hopping of providing some methodological guidance for future researches. |
| Key words: unit selection research for post-marketing drug clinical trial |
