中国临床药学杂志2025，Vol.34Issue(2)：118-123,6.DOI:10.19577/j.1007-4406.2025.02.007
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
谢江川 1谢林利 1潘辛梅 1曹丽亚 1马攀 1张馨 1陈勇川1
作者信息
- 1. 陆军军医大学第一附属医院药学部,重庆 400038
- 折叠
摘要
Abstract
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 118 projects 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Key words
clinical trials of drugs/prohibited drugs/improvement measures/Good Clinical Practice分类
药学引用本文复制引用
谢江川,谢林利,潘辛梅,曹丽亚,马攀,张馨,陈勇川..药物临床试验中禁用药的使用及改进措施[J].中国临床药学杂志,2025,34(2):118-123,6.
