中国临床试验核心指标集研究数据库平台构建

Construction of A Research Database Platform for the Core Outcome Set of Clinical Trials in China

核心指标集(Core Outcome Set,COS)的研制是解决当前临床试验结局指标异质性大、发表偏倚、不重要、不公认等共性问题的关键途径。为推动核心指标集研究发展,中国临床试验核心指标集研究中心(Chinese Clinical Trial Core Outcome Set,ChiCOS)建立了专业化数据库平台。本文从ChiCOS数据库平台的架构设计、平台功能与有效性试验核心结局指标(Core Outcome Measures in Effectiveness Trials,COMET)数据平台特点比较等方面,对ChiCOS数据库平台进行介绍,以期更好地为核心指标集研究提供技术支持。

The development of the core outcome set(COS)is a key way to solve the common problems of current clinical trial outcomes,such as large heterogeneity,publication bias,unimportance,and unrecognition.At present,the importance of COS research has received increasing attention,and the number of researches is gradually increasing.In order to promote the development of COS research,the Chinese clinical trial core outcome set(ChiCOS)has established a specialized database platform.The platform can collect and disseminate the latest results of COS research and organize training,facilitate COS research retrieval and information release,and serve COS research practice in China,especially in the field of Chinese medicine.At present,the design and construction of the database has been completed,and equipped with the COS Delphi automatic survey and data analysis system,which has been fully online and put into use in November 2020,becoming a technical support system for China′s effectiveness,safety and secondary research on COS related research.This paper introduced the ChiCOS database platform from the aspects of its design architecture,platform functions,and characteristics comparison with the COMET data platform,in order to better provide technical support for the research on the core outcome set.