抗肿瘤药物临床试验中风险评估与应对措施的探讨
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摘要
抗肿瘤药物临床试验因肿瘤患者自身的疾病特点、药物本身的特性、给药途径的特殊性等,常常存在较大风险。本文通过分析抗肿瘤药物临床试验中的自然风险和人为风险因素,从监管部门、研究者和伦理委员会的角度如何应对相应的风险进行探讨,从而加强抗肿瘤药物临床试验的风险管理,有效控制抗肿瘤药物临床试验的风险,更好地保障受试者和医护人员的安全。
Clinical trials of anti-tumor drugs are often at great risk due to the disease characteristics of tumor patients,the characteristics of drugs themselves,and the particularity of drug delivery routes. In this article,through analysis of anti-tumor drugs in clinical trials of natural and human risk factors,from the regulatory authorities,researchers and ethics committee discusses how to deal with the corresponding risk,so as to improve risk management of anti-tumor drugs in clinical trials,to effectively control the risk of anti-tumor drugs in clinical trials,to better protect the safety of the subjects and medical workers.
Clinical trials of anti-tumor drugs are often at great risk due to the disease characteristics of tumor patients,the characteristics of drugs themselves,and the particularity of drug delivery routes. In this article,through analysis of anti-tumor drugs in clinical trials of natural and human risk factors,from the regulatory authorities,researchers and ethics committee discusses how to deal with the corresponding risk,so as to improve risk management of anti-tumor drugs in clinical trials,to effectively control the risk of anti-tumor drugs in clinical trials,to better protect the safety of the subjects and medical workers.
引文
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[5]王瑾,汶柯,范贞.药物临床试验中受试者风险管理及基本权益保护[J].中国新药与临床杂志,2015,34(10):748-753.
[2]范华莹,谢振伟,王瓅珏,等.创新性药物临床试验的风险管理[J].中国临床药理学杂志,2017,33(23):2471-2473.
[3]董平平,张志敏,秦叔逵.临床试验伦理审查中风险与受益评估初探[J].中国医学伦理学,2016,29(4):639-641.
[4]夏侠,李媛媛,王坤,等.药物临床试验风险评估体系建立的初步探讨[J].中国临床药理学杂志,2016,32(8):753-755.
[5]王瑾,汶柯,范贞.药物临床试验中受试者风险管理及基本权益保护[J].中国新药与临床杂志,2015,34(10):748-753.