统计分析计划(SAP)报告指南的解读及其对中医药临床研究的启示

Interpretation of the Reporting Guidance of Statistical Analysis Plan( SAP) and Its Implications to Clinical Trials of Traditional Chinese Medicine

统计分析计划(SAP)是增加临床研究流程透明度、数据可信度、操作规范性、结果有效性和结论可接受度的途径之一,用于全面和翔实地记录临床研究方案中所描述的分析方法的原则,包括对主要变量、次要变量和其他数据的统计分析过程。SAP报告内容的指南共包括管理信息(11个条目/亚条目)、研究简介(2个条目)、研究方法 (9个条目/亚条目)、统计学原则(8个条目/亚条目)、试验人群(8个条目/亚条目)和分析(17个条目/亚条目) 6部分内容。SAP的发表可提升临床研究的效率,减少科研基金不必要的浪费;为临床试验阶段性成果的交流提供平台;提升试验从设计到报告的透明性;提高临床试验的可重复性。

Statistical analysis plan( SAP) is one of the methods to strengthen study transparency,data credibility,operating standardization,results validity and conclusion acceptability for comprehensively and informatively recording the principles of analysis described in clinical research protocols,including the statistical analysis of major variables,minor variables,and other data. The guidelines for SAP report content include management information( 11 items/sub-items),research profiles( 2 items),research methods( 9 items/sub-items),statistical principles( 8 items/sub-items),trials subjects( 8 items/sub-items) and analysis( 17 items/sub-items). The publication of SAP can improve the efficiency of clinical research,reduce unnecessary waste of research funds,provide a platform for the exchange of clinical trials,improve the transparency of design from report to report,and improve the repeatability of clinical trials.