重大传染病疫情中临床试验质量的保障和对策探讨——以新型冠状病毒肺炎为例  

Analysis and Countermeasures of the Clinical Trials Quality During the Major Infectious Disease Epidemic:Taking COVID-19 as an Example

作　　者：杜艾桦 尹平[2] Du Aihua(Department of Scientific Research Management,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,430030)

机构地区：[1]华中科技大学同济医学院附属同济医院科研处,武汉430030 [2]华中科技大学同济医学院公共卫生学院,武汉430030

出　　处：《医学与社会》2020年第5期36-41,共6页Medicine and Society

基　　金：“重大新药创制”科技重大专项,编号为2017ZX09304022。

摘　　要：针对新型冠状病毒肺炎疫情,各临床试验机构纷纷开展相关临床试验研究,以期在检测试剂、有效药物和疫苗等方面取得重大突破,为尽快战胜疫情提供帮助。然而重大传染病疫情下,井喷式增长的临床试验质量如何得到保障是一个应该特别关注的问题。本研究通过分析新型冠状病毒肺炎爆发以来武汉地区开展的临床试验项目情况和存在的问题,从项目统筹安排、伦理审查、质量保障和信息建设等角度提出相关思考和对策,以期促进重大疫情下临床试验健康、有序的发展。The clinical trials about COVID-19 are carrying out in various institutions,in order to find out the relevant diagnostic reagents,effective drugs or vaccines to overcome the epidemic.At the same time,the quality of those clinical trials is a problem should be paid attention during the epidemic period of major infectious disease.In order to promote the healthy and orderly development of clinical trials,this study analyzes the existing problems and countermeasures of the clinical trials in Wuhan from the aspects of clinical trial management,ethical review,quality assurance and informatization construction and so on.

关 键 词：新型冠状病毒肺炎 重大传染病疫情 临床试验 质量 

分 类 号：R197.3[医药卫生—卫生事业管理]