| 摘要: |
| 统计分析是药物临床试验整个过程中的一个重要环节,规范化的统计分析能真实地揭示药物的性能.本文针对药物临床试验统计分析存在的一些问题,依据国内外药物临床试验统计分析的有关法规,就统计分析的各个环节提出了一些具体的操作方法,用于保证临床试验的结果真实可靠. |
| 关键词: 临床试验、统计学,医学、规范 |
| DOI：10.3724/SP.J.1008.2006.00716 |
| 投稿时间：2006-05-10修订日期：2006-06-23 |
| 基金项目: |
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| Discussion on standard operation of statistical analysis in clinical drug trials |
| LU Jian,HE Jia,CAO Yang,MA Xiu-qiang,WU Cheng,SUN Ya-lin |
| (第二军医大学卫生勤务学系卫生统计学教研室,上海,200433) |
| Abstract: |
| Statistical analysis is an important step in clinical drug trial and standard statistical analysis can reveal the true characteristics of drugs. This paper reviews the existing problems in statistical analysis of clinical drug trials. Some specific operations concerning different steps of statistical analysis are tabled based on the international principles of statistical analysis for clinical drug trials, which may contribute to the reliability of the trial results. |
| Key words: clinical trials statistics,medical benchmarking |
