中医临床研究统计分析计划的优化_陆芳.pdf

( ) • 1261 • 中华中医药杂志 原中国医药学报 2010年8 月第25 卷第 8 期 CJTCMP , August 2010, Vol . 25, No.8 ·专题讲座· 1 1 2 陆芳 ，翁维良 ，田元祥 摘要： 关键词： 基金资助： Statistical analysis plans optimization of TCM clinical research 1 1 2 LU Fang , WENG Wei-liang , TIAN Yuan-xiang 1 2 ( Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091,China; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China) Abstract: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 fi nalising the protocol and should be fi nalised before treatment unblinding, to provide full details, even to the extent of including templates of tables, listings and fi gures 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 t