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药师参与肿瘤患者新药临床试验伦理审查典型案例分析
引用本文:刘斌. 药师参与肿瘤患者新药临床试验伦理审查典型案例分析[J]. 中国医院药学杂志, 2021, 41(17): 1756-1759. DOI: 10.13286/j.1001-5213.2021.17.10
作者姓名:刘斌
作者单位:湖北省肿瘤医院药学部, 湖北 武汉 430079
基金项目:湖北省卫生健康委员会指导性项目(编号:WJ2019F191);中国抗癌协会肿瘤临床药学专业委员会肿瘤药事质控标准研究项目(编号:Z19HBZL105)
摘    要:目的:探讨肿瘤患者新药临床试验中各种伦理问题的具体表现形式,为提高医疗机构伦理审查的质量和水平提供参考.方法:通过分析14例肿瘤患者新药临床试验典型案例,找出存在的伦理问题.结果:研究方案存在研究基础不充分、纳入排除标准不严谨、对照组设置不合理、揭盲时间不合理等问题;知情同意书存在告知信息不充分、语言表述不准确、补偿与...

关 键 词:肿瘤  临床试验  伦理问题  案例分析  药师
收稿时间:2021-02-09

A typical case study of pharmacist participating in ethical review of new drug clinical trials in cancer patients
LIU Bin. A typical case study of pharmacist participating in ethical review of new drug clinical trials in cancer patients[J]. Chinese Journal of Hospital Pharmacy, 2021, 41(17): 1756-1759. DOI: 10.13286/j.1001-5213.2021.17.10
Authors:LIU Bin
Affiliation:Department of Pharmacy, Hubei Cancer Hospital, Hubei Wuhan 430079, China
Abstract:OBJECTIVE To explore the specific manifestations of various ethical problems in clinical trials of new antitumor drugs and provide reference for improving the quality and level of ethical review in medical institutions.METHODS Through the analysis of 14 typical cases of clinical trials of new drugs for cancer patients, existing ethical problems were identified.RESULTS Some problems persisted in research protocols, such as insufficient research basis, lax inclusion and exclusion criteria, unreasonable setting of control group and unreasonable time for unblinding. Informed consent remained problematic, such as insufficient information, inaccurate language expression and unreasonable compensation and payment methods. There were some problems in amendment, such as exceeding the scope of amendment.CONCLUSION In clinical trials of new drugs for cancer patients, ethical risks are manifested in various forms. By participating in ethical review, pharmacist can boost the quality of ethical review and protect the rights and interests of subjects.
Keywords:tumor  clinical trial  ethical issues  case analysis  pharmacist  
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