摘要
临床试验是指新药物或新疗法获得卫生主管部门批准前,必须进行的小规模临床试验,是现今最为科学的医疗监管手段之一。新型冠状病毒疫情的暴发及常态化防控,给传统的临床试验的开展带来了诸多阻碍,而去中心化临床试验(DCT)在此背景下得到了广泛关注。疫情时期,中心访视成为受试者参与研究的主要障碍,而DCT利用“虚拟”工具获取试验数据,从而将受试者参与研究的障碍最小化。文章从DCT的理念、其在国内外临床试验中的应用现状和前景等方面进行综述。
As one of the most scientific means of medical supervision,clinical trials must be conducted to obtain approval from health authorities for a new drug or therapy.The outbreak of COVID-19 and the normalized epidemic prevention and control have brought many challenges to the conduction of traditional clinical trials.Decentralized clinical trials(DCTs)have received considerable attention in this context.During the COVID-19 pandemic,central visit became a major obstacle for subject participation in research.However,DCTs use"virtual"tools to obtain test data,thereby minimizing the obstacle.Therefore,DCTs have a broad application prospect.This article reviews the concept of DCTs and the current status and prospect of application in clinical trials.
作者
周凤
甘晨曦
徐亚文
姜敏
林莉
ZHOU Feng;GAN Chen-xi;XU Ya-wen;JIANG Min;LIN Li(National Drug Clinical Trial Institution of Jiangxi Provincial People’s Hospital,Nanchang 330006,China;Jiangxi Provincial Drug Administration,Nanchang 330029,China)
出处
《南昌大学学报（医学版）》
2023年第2期88-92,共5页
Journal of Nanchang University：Medical Sciences
基金
江西省药品监督管理局科研项目(2021KY06)。
