中国临床试验实施质量控制的发展与变革

Translated title of the contribution: Development and changes of quality control of clinical trials in China

王晓晖, 陈静, 李静 , 王蓓, 周琳, 李幼平, 吴泰相, 卞兆祥, 商洪才*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

临床试验的质量是决定一项临床研究的价值及能否进行成果转化的关键。本文梳理了我国临床试验实施质量控制各个阶段及中医药临床试验的质控特点,探寻我国临床试验质控的发展方向,以期不断提升我国临床试验的整体水平。

The quality of clinical trials is key to determine the value of a clinical research and whether it can transform achievements. In this paper, the characteristics and direction of the implementation of quality control in clinical trials in China, and the characteristics of quality control in clinical trials of Chinese medicine are discussed, and the development direction of quality control in clinical trials in China is explored in order to improve the overall level of clinical trials in China.

Translated title of the contributionDevelopment and changes of quality control of clinical trials in China
Original languageChinese (Simplified)
Pages (from-to)776-782
Number of pages7
Journal中国循证医学杂志
Volume18
Issue number8
DOIs
Publication statusPublished - 2018

Scopus Subject Areas

  • Medicine(all)

User-Defined Keywords

  • Clinical trial
  • Quality control
  • China
  • Change
  • 临床试验
  • 质量控制
  • 中国
  • 变革

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