摘要
目的积极应对新型冠状病毒肺炎疫情,加强早期临床试验病房的应急管理工作。方法根据国家相关政策,结合药物临床试验领域实际情况,从启动尽早应急响应机制、分类实施人员管理、适时调整试验工作流程、加强病区环境管理、设置应急观察病房、后续机制常态化建设6个方面,提出疫情期间早期临床试验病房的应急管理指引。结果与结论加强并完善疫情期间早期临床试验病房的应急管理工作,规范疫情期间的药物临床试验行为,可以避免或减少人员交叉感染,为全社会抗击疫情贡献力量。
Objective To actively respond to the coronavirus disease 2019(COVID-19)epidemic and strengthen the emergency response management of the early clinical trial ward.Methods According to the relevant national policies,combined with the actual situation in the field of drug clinical trials,the guidelines for emergency response management of early clinical trial wards during the epidemic period were put forward from six aspects:activating early emergency response mechanism,implementing personnel management by classification,timely adjusting the workflow of the clinical trial,strengthening the ward environmental management,setting up emergency observation ward and establishing mechanisms for normal operation.Results and Conclusion During the epidemic,strengthening and improving the emergency management of the early clinical trial ward and standardizing the drug clinical trial behavior can avoid or reduce the cross-infection of personnel and contribute to the fight against the COVID-19 epidemic.
出处
《中国药业》
CAS
2020年第7期42-45,共4页
China Pharmaceuticals
关键词
新型冠状病毒肺炎
药物临床试验
病房
疫情
应急管理
指引
coronavirus disease 2019
drug clinical trial
ward
epidemic
emergency response management
guidelines
作者简介
伍青,女,硕士研究生,主管护师,重庆大学附属肿瘤医院,研究方向为早期临床试验运行管理,(电子信箱)qingwuphase1@163.com;赵伟鹏,男,博士研究生,副主任医师,副教授,硕士研究生导师,天津医科大学肿瘤医院,研究方向为肿瘤转移、免疫治疗,(电子信箱)zhaoweipeng@tjmuch.com;郑寅涛,男,杭州师范大学整合肿瘤学研究院,研究方向为社会医学与公共卫生,(电子信箱)zyt@hznu.edu.cn。
