药物临床试验中禁用药的使用及改进措施  

Prohibition of drug use in clinical trials and improvement measures

作　　者：谢江川 谢林利 潘辛梅 曹丽亚 马攀 张馨 陈勇川 XIE Jiangchuan;XIE Linli;PAN Xinmei;CAO Liya;MA Pan;ZHANG Xin;CHEN Yongchuan(Department of Pharmacy,The First Affiliated Hospital of Army Medical University,Chongqing 400038,China)

机构地区：[1]陆军军医大学第一附属医院药学部,重庆400038

出　　处：《中国临床药学杂志》2025年第2期118-123,共6页Chinese Journal of Clinical Pharmacy

摘　　要：目的了解药物临床试验过程中禁用药的使用情况,探讨预防和减少禁用药使用的措施,为药物临床试验的规范化管理提供参考。方法以《药物临床试验质量管理规范》《药品注册核查要点与判定原则(2021年试行版)》《药物临床试验机构监督检查要点及判定原则(试行)》等法规为依据,对2018年1月-2024年5月我院118个药物临床试验项目中禁用药的使用情况进行梳理与分析。结果118个项目中共有36例次禁用药使用,其中13例次(占36.11%)由本科室授权的研究医师开具,11例次(占30.56%)为受试者于外院就诊时由外院医师开具,7例次(占19.44%)为受试者计划外随访时由本院其他科室或本科室非授权研究医师开具,5例次(占13.89%)为受试者自行于药店购买。经分析,导致禁用药使用原因中受试者病情需要17例次(占47.22%),受试者原因10例次(占27.78%),其他原因5例次(占13.89%),研究者原因4例次(占11.11%)。其中19例次禁用药使用并非必须使用,占比高达52.77%。结论避免或减少禁用药使用需多方协作,申办方、研究者、临床研究协调员(CRC)、机构办公室和伦理委员会需保持有效沟通,及时收集禁用药相关方案偏离信息,并开展针对性学习,确保临床试验的规范性。AIM To understand the use of banned drugs during drug clinical trials and explore measures to prevent and reduce the use of banned drugs,to provide a reference for the standardization of drug clinical trials.METHODS The study sorted out the relevant regulations,including Good Clinical Practice,Drug Registration Verification Points and Determination Principles(2021 Trial Version),and Key Points of Supervision and Inspection and Judgment Principles of Drug Clinical Trial Institutions(Trial).Statistically,it analyzed the use of prohibited drugs in the relevant projects managed by the author from January 2018 to May 2024.RESULTS A total of 36 cases of prohibited drug use in 118projects under management:13 cases were issued by the research doctor authorized by the department;11 cases were issued by the doctors of other hospitals;7 cases were subject to unplanned follow-up,which was issued by nonauthorized research doctors in other departments or undergraduate departments of the hospital;5 cases were purchased by the subjects themselves from the pharmacy,accounting for 36.11%,30.56%,19.44%and 13.89%respectively.After analysis,the patient's condition needed 17 items,10 items of prohibited drug use were caused by the reason of the subject,5 items were caused by other reasons,and 4 items were caused by the researcher,accounting for 47.22%,27.78%,13.89%and 11.11%respectively.A total of 19 prohibited drugs were not necessary,accounting for 52.77%.CONCLUSION Collaboration among various parties is essential to avoid or reduce the use of banned drugs in clinical trials.Sponsors,investigators,clinical research coordinators,institutional offices,and ethics committees must maintain effective communication.It is essential to promptly gather information on any protocol deviations related to banned drugs.Additionally,targeted training should be conducted to ensure the standardization of clinical trials.

关 键 词：药物临床试验 禁用药 改进措施 药物临床试验质量管理规范 

分 类 号：R954[医药卫生—药学]