抗肿瘤药物临床试验中受试者及研究者新冠肺炎风险控制  

Risk Control of Subjects and Investigators in Clinical Trial of Anti-cancer Drug During the Epidemic of COVID-19

作　　者：邓俊[1] 陈雪[1] 张锦 肖亚洲 王静[1] 李坤艳[1] DENG Jun;CHEN Xue;ZHANG Jin;XIAO Yazhou;WANG Jing;LI Kunyan(Department of Clinical Pharmaceutical Research Institution,Hunan Cancer Hospital,Changsha,Hunan,410013,China)

机构地区：[1]湖南省肿瘤医院药物临床试验机构,湖南长沙410013

出　　处：《肿瘤药学》2020年第S01期48-52,共5页Anti-Tumor Pharmacy

摘　　要：目前,新型冠状病毒肺炎(COVID-19)疫情防控进入攻坚阶段,及时有效的风险防控是抗击疫情的关键。抗肿瘤药物临床试验受试者及研究者是新型冠状病毒的重要易感人群,为保障受试者及研究者的安全和权益,本文针对新冠肺炎疫情下如何更好地开展药物临床试验工作,避免受试者、研究者间新型冠状病毒的爆发性传播,结合国家卫健委《新型冠状病毒肺炎诊疗方案》及相关抗肿瘤药物临床试验工作指引,提出受试者及研究者风险防护措施,为疫情期间抗肿瘤药物临床试验中的受试者和研究者提供安全保障。At present,the prevention and control of Coronavirus Disease 2019(COVID-19)has entered a crucial stage in China.Timely and effective risk control is the key to fighting the epidemic of COVID-19.Subjects and investigators in clinical trials of anti-cancer drugs are important susceptible populations to COVID-19 infection.In order to protect the safety and rights of the subjects and investigators,our study was aimed at how to better carry out clinical trials of drugs in the epidemic of COVID-19 and how to prevent the explosive transmission of novel coronavirus among subjects and investigators.We proposed the subjects and investigators risk control measures in clinical trials of antitumor drugs on the base of Diagnosis and Treatment of Coronavirus Disease 2019 issued by Chinese National Health Commission and related guidelines for clinical trials of anti-cancer drugs.

关 键 词：新冠肺炎 抗肿瘤药物临床试验 风险控制 受试者 研究者 

分 类 号：R95[医药卫生—药学]