目的:对中医临床研究项目的质量控制和管理进行研究.方法:在建立中医临床研究中期评估指标体系的基础上,根据相应的统计数据,利用因子分析法对中医临床研究进行中期评估.结果:在10个指标中提取了4个公因子,分别代表研究过程管理、电子数据管理、研究进度和二级监查管理,并建立中医临床研究中期综合评估模型.

This paper discusses the application of factor analysis in the mid-term evaluation of TCM clinical research. In attempt to study the quality control of TCM clinical research, factor analysis is used to evaluate the quality of mid-term TCM clinical research, based on the indicator framework for the quality control of TCM clinical research. Four latent factors are extracted from ten quantitative indicators. They are research process management factor, EDC management factor, research progressing factor and monitor report factor. Besides, a synthetic evaluation model of the mid-term TCM clinical research is established. As factor analysis eliminates the effect of human factors, it can be regarded as an objective evaluation method suitable for the mid-term evaluation of TCM clinical research.

科学技术部国家"十一五"科技支撑计划(2006BA104A21):中医临床研究的方案优化及质量控制研究，负责人：翁维良。