中医临床研究统计分析计划的优化  

Statistical analysis plans optimization of TCM clinical research

作　　者：陆芳[1] 翁维良[1] 田元祥[2] 

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中华中医药杂志》2010年第8期1261-1265,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金："十一五"国家科技支撑计划重大项目资助(No.2006BAI04A21);"重大新药创制"科技重大专项资助(No.2009ZX09301-005)~~

摘　　要：统计分析计划是临床研究中重要的指导性文件,其目的在于详细说明临床研究数据的统计分析方法和分析结果的描述方式。分析计划形成于研究方案制定之后,在数据揭盲之前定稿,并按预期的统计分析结果提供表格模板。研究方案和分析计划之间任何方法的修改都需要在统计分析计划中说明理由。为了提高中医临床研究的质量,有必要对统计分析计划进行优化。优化时需要从确定分析数据集和统计分析的指标、选择统计分析方法和统计软件等方面考虑。Statistical analysis plan （SAP） is an important guidance document in clinical research which is intended to be a comprehensive and detailed description of the methods and presentation of data analyses proposed for a clinical research. The analysis plan will be completed after finalising the protocol and should be finalised before treatment unblinding, to provide full details, even to the extent of including templates of tables, listings and figures to be presented in the statistical report. Any changes between the methods in the protocol and analysis plan will be explained in the analysis plan. In order to improve the quality of TCM clinical research, it is need to optimize the SAP. Considerations in optimizing the SAP include： determine the analysis sets and analysis variables, select analysis methods and statistical software.

关 键 词：中医临床研究 统计分析计划 优化 分析数据集 统计分析指标 统计分析方法 

分 类 号：R24[医药卫生—中医临床基础]