| 临床试验的数据和安全监察 |
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| 引用本文： | 邹建东,熊宁宁,汪秀琴,刘芳,蒋萌,符为民.临床试验的数据和安全监察[J].金属学报,2004,9(5):598-600. |
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| 作者姓名： | 邹建东 熊宁宁 汪秀琴 刘芳 蒋萌 符为民 |
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| 作者单位： | 南京中医药大学附属医院国家药品临床研究基地, 南京210029, 江苏 |
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| 基金项目： | 科技部“ 临床试验关键技术及平台研究” 项目(No2002AA2Z341i) |
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| 摘 要： | 临床试验数据和安全监察的目的是保证受试者的安全, 数据的有效性, 以及当明显的受益或风险被证实时, 或试验不可能成功获得结论时, 适时中止试验。所有的临床试验都应制定数据和安全监察计划;必要时需要建立数据和安全监察委员会。数据和安全监察的方法和强度应该与临床试验的风险以及试验规模和复杂程度相当。监察范围涉及试验实施的质量, 以及安全性和有效性的数据。监察类型包括对试验主要结局指标等监察项目进行连续地累积性评估和中期分析。
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| 关 键 词： | 数据和安全监察委员会 数据和安全监察计划 质量控制 中期分析 |
| 收稿时间： | 2004-02-01 |
| 修稿时间： | 2004-04-06 |
Data and safety monitoring in clinical trials |
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| ZOU Jian-Dong,XIONG Ning-Ning,WANG Xiu-Qin,LIU Fang,JIANG Meng,FU Wei-Min.Data and safety monitoring in clinical trials[J].Acta Metallurgica Sinica,2004,9(5):598-600. |
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| Authors: | ZOU Jian-Dong XIONG Ning-Ning WANG Xiu-Qin LIU Fang JIANG Meng FU Wei-Min |
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| Affiliation: | National Base for Drug Clinical Trial, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, Jiangsu, China |
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| Abstract: | The purpose of clinical data and safety monitoring is to insure the safety of participants, the validity of data, and the appropriate termination of studies for which significant benefits or risks have been uncovered or when it appears that the investigation cannot be concluded successfully.All clinical trials require data and safety monitoring plans, or data and safety monitoring board as necessary.The method and degree of data and safety monitoring must be commensurate with the degree of risk involved in participation in the trial and the size and complexity of the trial.The range of monitoring includes the quality of trial execution, safety data and efficacy data, while types of monitoring include continuous and cumulative evaluating trial outcome data and interim analyses |
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| Keywords: | data and safety monitoring boards data and safety monitoring plans quality control interim analyses |
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