中国科技期刊研究 ›› 2019, Vol. 30 ›› Issue (9): 962-976.doi: 10.11946/cjstp.201903260194

• 质量建设 • 上一篇    下一篇

中华医学会系列杂志稿约中临床试验注册规范的调查

李巍,张薇   

  1. 中国医科大学附属盛京医院《中国小儿急救医学》编辑部,辽宁省沈阳市和平区三好街36号 110004
  • 收稿日期:2019-03-26 修回日期:2019-08-19 出版日期:2019-09-15 发布日期:2019-09-15
  • 作者简介:李 巍(ORCID:0000-0002-0512-434X),硕士,副研究员,E-mail: cindylw555@163.com|张 薇,硕士,编辑。

Investigation on the requirements of clinical trial registration in the instructions for authors of Chinese Medical Association journals

LI Wei,ZHANG Wei   

  1. Editorial Office of Chinese Pediatric Emergency Medicine, Shengjing Hospital of China Medical University, 36 Sanhao Street, Heping District, Shenyang 110004, China
  • Received:2019-03-26 Revised:2019-08-19 Online:2019-09-15 Published:2019-09-15

摘要:

【目的】 了解目前国内医学期刊对临床试验注册制度的执行情况,为制定合理措施、推进临床试验注册制度的实施提供依据。【方法】 选择中华医学会系列杂志为调查样本,对122种期刊稿约中有关临床试验注册号的要求进行调查分析。【结果】 77种(63.1%)期刊在稿约中提出临床试验注册要求,并规定注册机构及注册号的排印位置和内容,没有期刊明确规定临床试验研究必须注册才能发表或推荐注册;大部分期刊从2014年开始在稿约中提出此项要求,且以二级标题的形式提出此项要求的期刊居多。【结论】 大部分中华医学会系列杂志在稿约中体现了临床试验注册制度,但仍是自愿原则。稿约对重要内容的规范和指导作用有待提高。国内医学期刊对临床试验注册的重视程度有待提高。

关键词: 临床试验注册, 中华医学会系列杂志, 医学期刊, 稿约

Abstract:

[Purposes] This study aims to analyze the current implementation of clinical trial registration in domestic medical journals, and to provide references for the development of reasonable measures and the implementation of clinical trial registration system. [Methods] We selected Chinese Medical Association journals as the samples to investigate and analyze the requirements of clinical trials registration in 122 journals. [Findings] Among the 122 journals, 77 journals (63.1%) have requirements for clinical trials registration in their instructions for authors, and stipulate the printing location and content of registration institution and registration number. There is no journal that clearly stipulates that clinical trial studies must be registered before publication or recommended registration. Most journals put forward this request in 2014, and most of them present this requirement in the form of a secondary title in the instructions for authors. [Conclusions] Most Chinese Medical Association journals reflect the clinical trial registration system in their instructions for authors, but it is still voluntary. The regulation and guiding function of the instructions for authors need to be improved. Domestic medical journals should pay more attention to clinical trial registration.

Key words: Clinical trial registration, Chinese Medical Association journal, Medical journal, Instructions for author