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

ZHANG Ying; WANG Liqiong; FEI Yutong; LI Xun; HAN Mei; ZHANG Xiatian; HU Yeyin; LIU Jianping

doi:10.13288/j.11-2166/r.2019.05.007

您当前的位置：

首页 >

文章列表页 >

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

更新时间：2021-11-10

- Interpretation of the Reporting Guidance of Statistical Analysis Plan（ SAP） and Its Implications to Clinical Trials of Traditional Chinese Medicine
- Journal of Traditional Chinese Medicine Vol. 60, Issue 5, Pages: 385-390(2019)
- 作者机构：
  
  1. 北京中医药大学中医学院
  2. 北京中医药大学针灸推拿学院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2019.05.007
  CLC： R24
- Published：2019
- 稿件说明：
移动端阅览
[1]张颖,王丽琼,费宇彤,李迅,韩梅,张夏天,胡烨胤,刘建平.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[J].中医杂志,2019,60(05):385-390.

ZHANG Ying, WANG Liqiong, FEI Yutong, et al. Interpretation of the Reporting Guidance of Statistical Analysis Plan（ SAP） and Its Implications to Clinical Trials of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2019, 60(5): 385-390.
[1]张颖,王丽琼,费宇彤,李迅,韩梅,张夏天,胡烨胤,刘建平.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[J].中医杂志,2019,60(05):385-390. DOI： 10.13288/j.11-2166/r.2019.05.007.

ZHANG Ying, WANG Liqiong, FEI Yutong, et al. Interpretation of the Reporting Guidance of Statistical Analysis Plan（ SAP） and Its Implications to Clinical Trials of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2019, 60(5): 385-390. DOI： 10.13288/j.11-2166/r.2019.05.007.

摘要

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。

Abstract

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.

关键词

Keywords

references

查看原文

Views

301

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Method and Implement Points of Random Cross-over Design in the Chinese Medicine Clinical Trial

Analysis of Registered Clinical Trials of Coronavirus Disease 2019: Existing Problems and Suggestions

Design and Application of Scale in Clinical Efficacy Evaluation of Traditional Chinese Medicine

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

LI Guolie's Experience in Treating Orthostatic Hypotension from the Perspective of "Raising the Clear and Directing the Turbid Downward"

Related Author

CHAI Qianyun

FEI Yutong

LIU Jianping

GUO Quan

CAI Linlin

XU Yun

ZHANG Tong

GUO Zhongning

Related Institution

Evidence-based Medicine Center,Beijing University of Chinese Medicine

Journal of Traditional Chinese Medicine

Xiyuan Hospital,China Academy of Chinese Medical Science

Institute of Basic research in Clinical Medicine,China Academy of Chinese Medical Sciences

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Address：No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing Postal code：100700
Tel：010-64035632 Email：jtcmcn@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备09064830号-19 京公网安备11010102007558号
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰