摘要
新型冠状病毒肺炎(COVID-19)作为一种新型呼吸道传染疾病,主要通过飞沫、接触、气溶胶等多条途径传播,在人与人之间具有广泛的传播性,潜伏期一般为0~14 d,且在潜伏期内也具有传染性。COVID-19的防控措施主要包括控制传染源、切断传播途径,保护易感人群。临床研究协调员(CRC)在临床试验的开展过程中需要与研究者、受试者、申办方密切接触,而且部分CRC工作地点不固定,管理模式不统一,这不仅增加了其感染新冠肺炎的风险,同时也增加了新冠肺炎的防控难度。因此,在新冠肺炎疫情防控期间如何做好不同模式下CRC的管理,降低感染风险,保证工作正常开展,成为临床试验现场管理公司(SMO)和药物临床试验机构共同面对的急迫问题。本文主要根据不同CRC管理模式的特点,结合新冠肺炎疫情防控期间我院针对CRC管理采取的一系列措施,以期为特殊时期CRC的管理提供参考和建议。
Coronavirus Disease 2019(COVID-19),a new respiratory infectious disease mainly transmitted by droplets,contact,aerosol and other means,has extensive individual transmission from person to person.It has an incubation period of 0~1 days and is also infectious during this period.The prevention and control measures mainly include controlling the source of infection,cutting off the transmission route and protecting vulnerable people.Clinical research coordinators(CRC)need to have close contact with investigators,subjects,and sponsors in the process of clinical trials.In addition,some CRC work sites are unfixed,and the management modes are unified among different trial centers.In such case,it not only increases the infection risk,but also aggravates the difficulty of epidemic prevention and control.Therefore,how to manage CRC under different management modes,reduce the risk of infection and ensure the normal operation has become an urgent problem faced by Site Management Organization(SMO)companies and drug clinical trial institutions.In this paper,we aimed to provide references and suggestions for the management of CRC in future special periods,based on the measures taken by our hospital for CRC protection and management.
作者
衡建福
刘洋
何丰
肖亚洲
王静
李坤艳
HENG Jianfu;LIU Yang;HE Feng;XIAO Yazhou;WANG Jing;LI Kunyan(Department of Clinical Pharmaceutical Research Institution,Hunan Cancer Hospital,Changsha,Hunan,410013,China;Beijing Linkstart Med-Tech Co.,Ltd.,Beijing,100020,China)
出处
《肿瘤药学》
CAS
2020年第S01期22-26,共5页
Anti-Tumor Pharmacy
关键词
新冠肺炎
抗肿瘤药物临床试验
CRC
管理模式
疫情
COVID-19
Anti-cancer drug clinical trial
CRC
Management model
Epidemic situation
作者简介
衡建福,男,博士,助理研究员,研究方向:药物临床试验,E-mail:hengjianfu@hnca.org.cn;第一作者:刘洋,男,博士,研究方向:药物临床试验,E-mail:liuyang@163.com;通讯作者:王静,女,医学博士,主任医师,研究方向:妇科肿瘤、药物临床试验,E-mail:wangjing@hnca.org.cn;通讯作者:李坤艳,女,药理学博士,副主任药师,研究方向:临床研究管理、药效药代动力学,E-mail:likunyan@hnca.org.cn。
