中国药物警戒 ›› 2010, Vol. 7 ›› Issue (4): 202-205.

• 循证药学 • 上一篇    下一篇

药物临床试验安全性报告的规范

邢建民, 李迅, 刘建平*   

  1. 北京中医药大学循证医学中心,北京 100029
  • 收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-04-08 发布日期:2016-02-19
  • 通讯作者: 刘建平,男,博士研究生导师,循证中医药临床研究。E-mail:jianping_liu@fagmed.uit.no
  • 作者简介:邢建民,男,医学统计学讲师,中医药临床疗效评价方法学。
  • 基金资助:
    国家重点基础研究发展计划（973计划）（No; 2006CB504602）; 科技部国际合作项目（2009DFA31460）

A Proposal for Safety Reporting of Drug Randomized Controlled Trials

XING Jian-min, LI Xun LIU, Jian-ping*   

  1. Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2016-02-19 Revised:2016-02-19 Online:2010-04-08 Published:2016-02-19

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摘要： 从药物临床试验的定义及各分期对安全性的要求强调安全性报告的重要性。简单介绍药物临床试验安全性报告的现状,并对CONSORT声明扩展版中针对药物有害性临床试验报告的标准及条目进行解释。

关键词: 安全性, 不良事件, 临床试验, Consort声明, 中药

Abstract: To introduce the importance of safety reporting in clinical trials from the aspect of drug clinical trial's defi-nition and classification of different stages, briefly summarize the current situation of safety reporting in drug clinical trials, and explain the reporting standards of drug clinical trials based on the recommendations of Consort extension on harm.

Key words: safety, adverse event, clinical trial, Consort statement, Chinese Traditional Medicine

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