重视临床试验设计,提升中国临床试验质量

Translated title of the contribution: Attaching importance to the design process to improve the quality of clinical trials in China

赵晨, 林伟青, 田然, 杨桢, 吕爱平, 商洪才*, 卞兆祥

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

临床试验证据是目前各级卫生健康决策的主要依据。近年随着国家新药临床试验数据核查等工作推进,显露出的问题为我国临床研究质量敲响了警钟。在加强临床试验过程管理、执行监督等实施环节之外,我们呼吁重视试验设计与实施的连贯性和一致性,将提升临床试验设计水平列入提高临床研究质量的议事日程,并提出相关的合理化和规范化建议。以期能从临床试验源头厘清研究思路,避免违背研究方案行为,提升中国临床试验质量。

Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process management and supervision, we call attention to the coherence and consistency of trial design and implementation, including the promotion of clinical trial design in the agenda of improving the quality of the trials and putting forward reasonable suggestions. We hope that our work could make research ideas clear from the source of a clinical trial, with a view to avoid violating protocol behavior and provide standardized recommendations for improving the quality of clinical trials in China.

Translated title of the contributionAttaching importance to the design process to improve the quality of clinical trials in China
Original languageChinese (Simplified)
Pages (from-to)645-647
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

  • Clinical problems
  • Clinical trial design
  • Clinical trial methodology
  • Clinical trial quality
  • Control Design

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