复杂网络视角下国际多中心临床试验机构合作趋势探究  

Research on the trend of cooperation among institutions of international multi-center clinical trials from the perspective of complex networks

作　　者：郑增亮 蔡晓琼 苏前敏[1] 黄继汉[2] 于挺[3] ZHENG Zeng-liang;CAI Xiao-qiong;SU Qian-min;HUANG Ji-han;YU Ting(College of Electrical and Electronic Engineering,Shanghai University of Engineering Science,Shanghai 201620,China;Center for Drug Clinical Research,Shanghai University of Chinese Medicine,Shanghai 201203,China;School of Management,Shanghai University of Engineering Science,Shanghai 201620,China)

机构地区：[1]上海工程技术大学电子电气工程学院,上海201620 [2]上海中医药大学药物临床研究中心,上海201203 [3]上海工程技术大学管理学院,上海201620

出　　处：《中国新药杂志》2022年第16期1574-1579,共6页Chinese Journal of New Drugs

基　　金：国家重大新药创制科技重大专项资助项目(2018ZX09711001-009-011);上海市2017年度科技创新行动计划资助项目(17401970900);2019年上海市人民政府决策咨询重点专项资助项目(2019-AZ-018-B)。

摘　　要：目的:挖掘国际多中心临床试验国际合作趋势与特征,在新药研发国际化背景下,为监管部门推动国内多中心临床试验发展提供启示与借鉴。方法:基于美国临床试验注册中心(ClinicalTrials.gov)网站的数据,采集并分析2000—2020年国际多中心临床试验数据,运用复杂网络方法进行数据分析与特征挖掘。结果:自2000—2020年,国际多中心临床试验机构的合作网络规模不断扩大,合作紧密度不断增强,机构合作网络具有无标度特性。结论:国际多中心临床试验合作网络的规模呈扩大趋势,未来国际多中心临床试验机构间合作应该向着加强国际机构间合作紧密度的方向迈进。Objective:To explore the trend and characteristics of international cooperation in multicenterclinical trials,and provide inspiration and reference for regulatory authorities to promote the development of domesticmulticenter clinical trials in the context of internationalization of new drug R&D.Methods:Based on data from theClinicalTrials.gov website of the US Clinical Trials Registry,we collected and analyzed international multicenterclinical trial data from 2000 to 2020 and applied complex network method for data analysis and feature mining.Results:From 2000 to 2020,the scale of cooperation network of international multicenter clinical trial institutionshad been expanding,the cooperation degree was increasing,and the cooperation network of international multicenterclinical institutions has scale-free characteristics.Conclusion:The scale of international multicenter clinical trialcooperation network is expanding,and the future cooperation among international multicenter clinical trial institutionsshould move toward the direction of increasing the tightness of cooperation among international institutions.

关 键 词：临床试验注册 合作网络 复杂网络分析 国际多中心临床试验 无标度 

分 类 号：R969.4[医药卫生—药理学]