中医药临床试验中统计分析计划的制定

Development of Statistical Analysis Plan in Clinical Trials in Traditional Chinese Medicine

统计分析计划是临床试验方案设计中的重要组成部分,是充分利用数据、临床结果合理可靠的必要条件。目前中医药临床试验中存在统计分析计划缺失或不完整、统计分析方法缺少或描述不清、统计方法选择不当、比较类型与试验目的不符等诸多问题。针对以上问题,应根据中医药临床研究的特点来制定统计分析计划,如根据试验目的确定比较类型、根据干预的主要和次要结局以及结局评价指标建立假设。此外,统计分析计划应包括临床试验概要的简要说明、样本含量及统计学把握度的设定、确定统计分析方法、确定统计分析数据集等其他多项内容。

As an important part in clinical trial design, statistical analysis plan is necessary for full utilization of data and reasonableness and reliability of clinical results. There are many problems in statistical analysis of TCM clini- cal trials such as missing or incomplete statistical analysis plan, lack of statistical methods, unclear description or im- proper selection of statistical methods and mismatched comparison type and testing purpose. In order to solve the above problems, statistical analysis plan should be developed according to the characteristics of TCM clinical research such as determining comparison type according to the purpose of trial and establishing assumption based on the prima- ry and secondary outcomes of intervention and the outcome evaluation. Furthermore, statistical analysis plan should include a brief description of clinical trial and the determination of sample size, statistical power, statistical methods and statistical analysis dataset.