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临床试验中样本量确定的统计学考虑 被引量:92

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摘要 样本量确定(sample size determination),又称样本量估计(sample size estimation),是指为满足统计的准确性和可靠性(I类错误的控制和检验效能的保证)计算出所需的样本量,它是临床试验设计中一个极为重要的环节,直接关系到研究结论的可靠性、可重复性,以及研究效率的高低。
作者 陈平雁
机构地区 CCTS工作组
出处 《中国卫生统计》 CSCD 北大核心 2015年第4期727-731,733,共6页 Chinese Journal of Health Statistics
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参考文献12

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二级参考文献6

  • 1Committee for Proprietary Medicinal Products (CPMP). Points to Con- sider on Multiplicity issues in clinical trials, http ://www. ema. europa. eu/docs/en _ GB/document _ library/Scientific _ guideline/2009/09/ WC500003640. pdf.
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