摘要：

【目的】 分析我国高影响因子医学期刊临床试验注册和发表机制的实施现状,为该机制的合理实施提供参考。【方法】 选择20种高影响因子医学期刊为调查对象,对其前瞻性临床试验论文的临床试验注册相关内容进行调查,并且进一步验证临床试验注册号的正确性、论文报道内容和临床试验注册内容的一致性。【结果】 376篇前瞻性临床试验论文中,仅28篇(7.4%)标注临床试验注册机构和注册号。其中,4篇(14.3%)论文的临床试验注册相关内容与期刊稿约要求不一致,4篇(14.3%)论文的临床试验注册号错误,3篇(10.7%)论文的发表内容和临床试验注册内容不一致。11种(55.0%)期刊的稿约中要求标注临床试验注册机构和注册号,但均未作强制性要求。【结论】 我国医学期刊对临床试验注册和发表机制的执行不严格,仅遵循自愿原则。医学期刊编辑和临床研究者对临床试验注册的重视程度均有待提高。医学期刊可根据自身的情况,有针对性地实施临床试验注册和发表机制。

关键词: 前瞻性临床试验, 临床试验注册, 医学期刊, 医学论文, 稿约声明

Abstract:

[Purposes] This paper aims to analyze the implementation status of clinical trial registration and publishing mechanism of medical journals in China with high impact factors, and to provide references for the reasonable implementation of this mechanism. [Methods] A total of 20 medical journals with high impact factors were selected as survey objects. We investigated the clinical trial registration related content of prospective clinical trial papers in these 20 journals, and further verified the correctness of the clinical trial registration number and the consistency of the contents between the articles and clinical trial registration. [Findings] Among the 376 articles, 28 articles (7.4%) are marked with clinical trial registration institution and registration number. Among them, clinical trial registration related contents in 4 articles (14.3%) are inconsistent with the requirements of instructions for authors, the clinical trial registration number in 4 articles (14.3%) is wrong, and the published contents in 3 articles (10.7%) are inconsistent with the clinical trial registration contents. The instructions for authors of 11 journals (55.0%) require the clinical trial registration institution and registration number to be marked, but none of them make mandatory requirements. [Conclusions] Medical journals in China do not have strict requirements for clinical trial registration and publishing mechanism, and only follow the voluntary principle. Medical journal editors and clinical researchers should give more emphasis on clinical trial registration. Medical journals could implement clinical trial registration and publishing mechanism according to their own conditions.

Key words: Prospective clinical trial, Clinical trial registration, Medical journal, Medical article, Instructions for authors