规范多中心临床试验势在必行

董冲亚, 阎小妍, 姚亮, 卞兆祥*, 姚晨

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

随着国家政策对于药品、医疗器械创新的鼓励,我国开展的多中心临床试验和参与的国际多中心临床试验迎来了前所未有的发展契机。在越来越多的临床试验采用多中心设计的同时,我们需要看到目前存在的不足之处。本文从多中心临床试验设计、实施和报告三个阶段归纳汇总多中心临床试验面临的问题与挑战。从降低中心异质性、避免中心效应的角度出发,建议制定多中心临床试验的设计、实施和报告规范,以提高多中心临床试验质量。

With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.

Original languageChinese (Simplified)
Pages (from-to)654-656
Number of pages3
Journal中国循证医学杂志
Volume18
Issue number7
DOIs
Publication statusPublished - Jul 2018

Scopus Subject Areas

  • Medicine(all)

User-Defined Keywords

  • Design
  • Guideline
  • Implementation
  • Multi-center clinical trial
  • Reporting

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