| 我国新药临床试验的风险管理模式探讨 |
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| 引用本文： | 薛薇,董凡,李可欣.我国新药临床试验的风险管理模式探讨[J].中国药物警戒,2014(8):488-491. |
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| 作者姓名： | 薛薇 董凡 李可欣 |
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| 作者单位： | 北京医院药学部药物临床风险与个体化应用评价北京市重点实验室,北京100730 |
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| 基金项目： | 国家科技部十二五重大新药创制一心脑血管疾病新药临床评价技术平台研究课题（2012ZX09303-008-002） |
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| 摘 要： | 目的从临床试验研究者的角度探索新药临床试验的风险管理模式,为其在我国的建立与实施提供参考。方法分析风险管理的通用模式与架构,借鉴发达国家成熟药品风险管理体系的法规与原则,阐述我国新药临床试验风险管理的发展现状,开拓创新适合我国国情的风险管理模式。结果与结论 基于一般风险管理及药品风险管理的理论与实践,提出适合我国新药临床试验的风险管理新模式的构想。
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| 关 键 词： | 新药临床试验 风险管理 风险管理模式 |
Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China |
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| XUE Wei,DONG Fan,LI Ke-Xin.Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China[J].Chinese JOurnal of Pharmacovigilance,2014(8):488-491. |
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| Authors: | XUE Wei DONG Fan LI Ke-Xin |
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| Institution: | (Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Pharmacy, Beijing Hospital, Beijing 100730, China) |
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| Abstract: | Objective To provide references for establishment and implementation of risk management in new drug clinical trials, from the perspectives of investigators. Methods General modes and constructions of risk management were analyzed, and regulations and principles for drug risk management in developed country were used for comprehensive references. Moreover, the present situation of drug risk management in clinical trial in China was discussed. Results and Conclusion Based on the preliminary exploration, we proposed the new risk management mode for clinical trials of new drugs suitable for China. |
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| Keywords: | new drug clinical drugs trials suitable for China risk management risk management mode |
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