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.
作者
郑增亮
蔡晓琼
苏前敏
黄继汉
于挺
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)
出处
《中国新药杂志》
CAS
CSCD
北大核心
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)。
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
clinical trial registration
collaborative networks
complex network analysis
internationalmulticenter clinical trials
scale-free