摘要
2019年12月严重急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)感染的肺炎爆发以来,疫情防控形势愈发严峻。为加强疫情防控工作,有效防止疫情扩散和蔓延,全国各省市相继启动重大公共卫生事件Ⅰ级响应,大量的临床试验项目也不得不暂停随访、入组。其中药物管理是药物临床试验的重要环节,为积极响应国家要求,各地临床试验机构纷纷启动了一系列应急管理措施,应对疫情形势下受试者的随访给药管理,确保相关研究人员与受试者生命健康安全,探讨制订临床试验机构中心药房管理制度,旨在维护受试者的权益,保证临床试验安全、有序、顺利地开展。
Since the outbreak of pneumonia caused by severe acute vespiratory syndrome coronavirus 2. December 2019, the situation of epidemic prevention and control has become more serious. In order to strengthen the prevention and control of the epidemic and effectively prevent the spread, provinces and cities across the country have successively initiated grade I responses to major public health events. A large number of clinical trials have been obliged to suspend follow-up and group joining. Drug management is an important part of drug clinical trials. In order to actively respond to national requirements, clinical trial institutions around the country have launched a series of emergency management measures to respond to the administration of follow-up drug delivery in an epidemic situation and ensure safety of relevant researchers and participants. We hereby discuss the formulation of a central pharmacy management system for clinical trial institutions, with a view to safeguard the rights and interests of participants and ensure carrying out clinical trials safely, orderly and successfully.
作者
贾雨婷
蔡芸
梁蓓蓓
王瑾
JIA Yu-ting;CAI Yun;LIANG Bei-bei;WANG Jin(Clinical Medicine Research Center,Chinese People's Liberation Army General Hospital,Beijing 100853,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第7期762-765,共4页
Chinese Journal of New Drugs
基金
国家“重大新药创制”科技重大专项资助项目(2018ZX09201013)
防治重大疾病创新药国际标准化临床评价示范性技术平台建设。
关键词
临床试验
中心药房
药物管理
重大突发公共卫生事件
clinical trials
central pharmacy
medicine management
major public health emergencies
