摘要
新型冠状病毒肺炎(以下简称“新冠肺炎”)疫情常态化防控期间,发热临床试验项目运行面临诸多问题,影响新药研发。如何把新冠肺炎疫情常态化防控与临床试验流程相协调,是保障疫情常态防控下发热临床试验项目受试者顺利入组的关键。本文以流行性感冒项目为例,结合我院流行性感冒临床试验项目的运行和管理的工作实践,探讨新冠肺炎疫情常态化防控期间发热临床试验项目运行面临问题及对策建议。为了适应开展传染病防控与临床试验的双重需求,建议在新冠肺炎疫情低风险区域,将临床试验入组筛查流程与排除新冠肺炎的流程有机结合起来考虑,受试者筛查关口前移,在等待排除新冠肺炎筛查结果时同步进行临床试验入组筛查,同时预先制定新冠肺炎筛查结果回报后的临床试验流程。
During the regular COVID-19 prevention and control period,the running of fever-related clinical trial projects faces many problems,which will affect the development of new drugs.How to coordinate the regular COVID-19 prevention and control with the clinical trial process is the key to ensure that the clinical trial participants are successfully enrolled.In this paper,taking the influenza project as an example,combined with the practice of operation and management of the influenza clinical trial project in our hospital,the problems faced in the operation of fever-related clinical trial projects during the regular COVID-19 prevention and control period were discussed and the countermeasures and suggestions were proposed.In order to meet the dual needs of infectious disease prevention and control and clinical trials,it is recommended that in low-risk areas for COVID-19,the subject screening process be integrated with the COVID-19 exclusion process,the starting time of subject screening be moved forward,clinical trial enrollment be conducted while waiting for COVID-19 screening results,in addition,the clinical trial process after COVID-19 screening results are returned should be established in advance.
作者
程金莲
朱雪琦
刘琳
肖爽
王烁
王彦
刘清泉
CHENG Jin-lian;ZHU Xue-qi;LIU Lin;XIAO Shuang;WANG Shuo;WANG Yan;LIU Qing-quan(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第18期1804-1809,共6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:创新药物全过程临床评价示范性技术平台建设(2019ZX09734001)
北京中医医院院级课题暨两院合作项目:调肝安神颗粒治疗原发性失眠的成药性研究
基于风险评估的临床科研课题全过程质量控制工具的研究(LY201801,LY201807)。
