| 等效性临床试验等效界值确定原则的探讨 |
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| 引用本文： | 朱泉,梁伟雄.等效性临床试验等效界值确定原则的探讨[J].金属学报,2005,10(8):957-960. |
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| 作者姓名： | 朱泉 梁伟雄 |
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| 作者单位： | 广州中医药大学DME 中心, 广州 510405, 广东 |
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| 摘 要： | 等效界值的确定是等效性试验设计中最为困难的部分,其确定方法必须保证试验措施相对于安慰剂的有效性,并且必须在分析既往研究的基础上结合统计学意义、临床意义、结局指标的选择、疾病具体特征,并考虑毒副作用、风险-效益的分析等事先做出。本文论述了等效性临床试验设计中确定等效界值的一般原则。
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| 关 键 词： | 等效性试验 临床试验设计 等效界值 临床意义 |
| 收稿时间： | 2005-06-30 |
| 修稿时间： | 2005-08-04 |
Principles to specify equivalence margin in clinical trials |
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| ZHU Quan,LIANG Wei-xiong.Principles to specify equivalence margin in clinical trials[J].Acta Metallurgica Sinica,2005,10(8):957-960. |
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| Authors: | ZHU Quan LIANG Wei-xiong |
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| Affiliation: | DME Center, Guangzhou University of TCM, Guangzhou 510405, Guangdong, China |
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| Abstract: | This paper deals with the principles and approaches to specify the equivalence margin in equivalence or non-inferiority trials.It is a difficult work to define equivalence boundary appropriately in clinical trials design.The selection of equivalence margin should provide assurance the effectiveness of experimental treatment relative to placebo firstly.Based on the analysis of previous studies, the statistical reasoning, clinical relevant, the choice of clinical outcome, the characteristics of particular diseases, toxicity, adverse effects, and risk-benefit assessment must be considered for equivalence margin pre-specified reasonably. |
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| Keywords: | equivalence trial clinical trial design equivalence margin clinical relevant |
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