临床试验报告规范及国内临床试验报告存在的问题及对策

Challenges and countermeasures of clinical trial reporting standard and domestic clinical trial reporting

临床试验报告是临床试验完成后将试验的整个过程和结果呈现给公众的文件,也是最终研究成果评价与鉴定的主体,为了提高报告质量,临床试验报告统一标准——CONSORT声明于1995年应运而生。本文从临床试验报告规范制定的背景及发展入手,介绍了临床试验报告规范的现状,总结了当前CONSORT声明的40个扩展声明。通过系统分析CONSORT声明发表近30年来关于临床研究报告质量评价的文献,结合实践经验,分析了国内临床试验在报告研究设计与统计分析方面存在的不足,并提出了相应的对策建议,为临床研究者实施和报告高质量的研究提供参考。

A clinical trial report is a document that presents the entire process and results of a clinical trial to the public after the completion of a clinical trial, and is also the subject of the evaluation and identification of the final research results. The CONSORT Statement, a unified standard for clinical trial reporting, was published in 1995 to improve reporting quality. Starting with the background and development of clinical trial reporting standards, this paper introduces the current status of clinical trial reporting standards, and summarizes the 40 extensions of the current CONSORT declaration. Through systematic analysis of the literature on the quality evaluation of clinical research reports in the past 30 years since the CONSORT statement was published, combined with practical experience, our paper analyzes the shortcomings in the reporting study design and statistical analysis of domestic clinical trials, and put forward corresponding countermeasures and suggestions, so as to provide reference for clinical researchers to implement and report high-quality studies.