今日药学

2022, v.32(03) 198-201

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新型冠状病毒肺炎疫情下药物临床试验机构管理策略
Management Strategy of Drug Clinical Trial Institutions During the Coronavirus Disease 2019 Epidemic

何雪兰;杨旭;苏钿欢;杨若琳;黄凯鹏;
HE Xuelan;YANG Xu;SU Tianhuan;YANG Ruolin;HUANG Kaipeng;Guangzhou Eighth People's Hospital,Guangzhou Medical University;

摘要(Abstract):

新型冠状病毒肺炎(COVID-19)自2019年12月爆发以来,全球各行业均受影响,药物临床试验也不可避免。如何在做好新型冠状病毒肺炎疫情防控工作前提下,加速临床试验进程,提升药物临床试验机构管理水平,是药物临床试验机构面临的问题。本文以某院药物和医疗器械临床试验机构管理模式为基础,从临床试验项目管理各方面包括立项审核、伦理委员会审查、项目启动、人员管理、药物管理、数据收集和项目质控进行分析,提出相应的管理策略,使临床试验项目科学有序开展。
Since the outbreak of the coronavirus disease 2019(COVID-19) epidemic in December 2019,all industries around the world have been affected. And drug clinical trials are also inevitable. Drug clinical trial institutions are facing many problems. How to improve the management level of drug clinical trial institutions and accelerate the progress of clinical trials under the premise of preventing and controlling coronavirus disease 2019(COVID-19) epidemic needs further attentions. Based on the management model of clinical trial institutions for drugs and medical devices in a hospital, the current study analyzes all aspects of clinical trial project management, including project review, ethics committee review, project initiation, personnel management, drug management, data collection and project quality control, and proposes corresponding strategies and measures to make the clinical trial project work scientifically and orderly.

关键词(KeyWords): 新型冠状病毒肺炎;药物临床试验;管理策略
COVID-19;drug clinical trial;management strategy

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作者(Authors): 何雪兰;杨旭;苏钿欢;杨若琳;黄凯鹏;
HE Xuelan;YANG Xu;SU Tianhuan;YANG Ruolin;HUANG Kaipeng;Guangzhou Eighth People's Hospital,Guangzhou Medical University;

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