新型冠状病毒肺炎疫情下开展健康受试者Ⅰ期临床试验的思考  

Reflection on the Development of Phase Ⅰ Clinical Trials in Healthy Volunteers During the COVID-19 Pandemic

作　　者：张冬林[1] 杨婧雯 陈倩[1] 雷永芳[1] ZHANG Donglin;YANG Jingwen;CHEN Qian;LEI Yongfang(Laboratory of Phase I Clinical Trial,Department of Pharmacy,Tongji Hospital,Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部Ⅰ期临床试验研究室,武汉430030

出　　处：《医药导报》2020年第8期1054-1057,共4页Herald of Medicine

基　　金：“重大新药创新”科技重大专项资助项目(2017ZX09304022)。

摘　　要：该文对新型冠状病毒肺炎(COVID-19)疫情下开展Ⅰ期临床试验面临的问题和尚需进行改进的措施作初步的分析。从COVID-19疫情下开展临床试验的防范措施、合理调整临床试验方案设计、受试者管理等方面提出管控对策,力图做好疫情防控,保障受试者、临床试验相关人员的健康安全,避免交叉感染,最大限度地降低医院感染和疫情传播风险,为重大传染病疫情下开展Ⅰ期临床试验提供借鉴。Under the coronavirus disease 2019(COVID-19) pandemic, this study is to make a preliminary analysis of the current problems and the measures to be improved in conducting phase Ⅰ clinical trials.From the aspects of preventive measures, reasonable adjustment of clinical trial scheme design, subject managements for clinical trials under the COVID-19 epidemic situation, and control countermeasures were put forward to prevent and control the pandemic situation, ensure the health and safety of volunteers and relevant practitioners of clinical trials, avoid cross-infection, and minimize the risk of hospital infection and pandemic spread. This study provides a reference for the development of phase Ⅰ clinical trials in the period of major infectious diseases.

关 键 词：新型冠状病毒肺炎 Ⅰ期临床试验 健康安全 交叉感染 

分 类 号：R969[医药卫生—药理学] R511[医药卫生—药学]