专职研究护士对提升药物临床试验质量的作用浅析  

Analysis of role of full-time research nurses in improving quality of drug clinical trials

作　　者：廖娟[1] 刘寰 陈恩强[1] 唐红[1] LIAO Juan;LIU Huan;Chen Enqiang;TANG Hong(Center of Infectious Diseases,West China Hospital of Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西医院感染性疾病中心,四川成都610041

出　　处：《药物评价研究》2020年第9期1923-1926,共4页Drug Evaluation Research

基　　金：北京医卫健康公益基金会课题(YWJKJJHKYJJ-B184091-Q21)。

摘　　要：药物临床试验是新药研发过程中极其重要的阶段,临床试验完成质量的高低直接关系到人类的生命与健康,因此必须保证药物的安全、有效和质量控制。专职研究护士在现今的药物临床研究试验中扮演着多重角色,对临床试验的质量起到了一定的保障作用。依据临床试验的相关法律法规,结合自身工作经验,浅析临床试验中常见问题发生的原因、处理及预防措施,以期提高专职研究护士的作用,从而提升药物临床试验的质量。Drug clinical trial is an extremely important stage in the process of new drug research and development.The quality of clinical trial completion is directly related to human life and health.So,it is necessary to ensure the safety,effectiveness and quality control of drugs.Full-time research nurses play multiple roles in today’s drug clinical research trials and play a certain role in guaranteeing the quality of clinical trials.Based on the relevant laws and regulations of clinical trials,combined with the author’s own work experience,this paper analyzed the causes,treatment and preventive measures of common problems in clinical trials,with a view to improving the role of full-time research nurses and improving the quality of drug clinical trials.

关 键 词：专职研究护士 药物临床试验 质量 作用 

分 类 号：R288.4[医药卫生—中药学]