摘要
目的通过对药物临床试验项目自查中发现的问题进行初步分析和探讨,以期加强人类遗传资源的风险控制,提高药物临床试验质量。方法本文结合医疗机构按专项检查要求自查中发现的问题,分析人类遗传资源管理风险点并提出防控建议。结果药物临床试验过程复杂且耗时长,存在一些不符合人类遗传资源管理规定的情况,过程监管存在风险点。结论医疗机构应建设独立的人类遗传资源管理部门,完善相关管理制度和标准操作规程,建立长效监督机制,加强政策宣贯和培训力度,保障药物临床试验质量。
OBJECTIVE To strengthen the risk control of human genetic resources and improve the quality of drug clinical trials through the preliminary analysis and investigation the problems found in the self-audit of drug clinical trials.METHODS Combined with the problems found in the self-auditin medical institutions according to the special inspection requirements,the risk points of human genetic resources management were analyzed,and the precaution and control advice was put forward.RESULTS The process of drug clinical trial was complex and time-consuming,where some cases did not comply with the regulations on human genetic resources management,and there were some risk points in the process supervision.CONCLUSION Medical institutions ought to build an independent human genetic resources management department,improve relevant management systems and the standard operating procedures,establish a long-term supervision system,strengthen policy publicizing,implementation and training,and ensure the quality of drug clinical trials.
作者
郑佳冰
施小勇
陈玉玲
ZHENG Jia-bing;SHI Xiao-yong;CHEN Yu-ling(Fujian Medical University Union Hospital,Fuzhou 350001,China)
出处
《海峡药学》
2021年第12期232-234,共3页
Strait Pharmaceutical Journal
基金
福建省财政专项经费闽财指2020467,项目编号2020CZ004。
