探讨药物临床试验生物样本流通环节常见问题及风险前置化管理措施  

Discussion of Common Problems with Biological Samples during Drug Clinical Trials and Pre-Risk Management Measures

作　　者：赵同香[1] 蒋向明[1] 王海英[1] 马丽萍[1] ZHAO Tong-xiang;JIANG Xiang-ming;WANG Hai-ying;MA Li-ping(Peking University Shougang Hospital)

机构地区：[1]北京大学首钢医院

出　　处：《中国食品药品监管》2021年第3期44-51,共8页China Food & Drug Administration Magazine

摘　　要：目的:回顾性分析药物临床试验生物样本流通环节的常见问题和原因,探讨风险前置化管理措施。方法:总结2012年7月~2019年12月本院临床试验质控过程中发现的生物样本流通环节的问题,分析原因并提出可行的风险前置化管理措施。结果:本院已结题的78项临床试验项目质控记录表共计236份,包含44个生物样本流通环节的问题。其中,生物样本相关知情同意问题2个(2/44,4.55%)、样本采集环节问题16个(16/44,36.36%)、样本处理环节问题8个(8/44,18.18%)、样本保存和运输/转运环节问题16个(16/44,36.36%)、生物样本人类遗传资源管理问题2个(2/44,4.55%)。其可能原因包括:样本管理人员未按照方案和样本管理的标准操作规程(standard operating procedure,SOP)处理样本、样本分析相关仪器设备未及时校准和受试者依从性差等。根据可能原因,共提出7条可行的前置化风险防范措施。结论:样本采集、保存和运输环节的问题是临床试验生物样本流通环节最常见的问题,采取风险前置化管理措施,并结合临床试验的全过程质控,可进一步提高临床试验生物样本流通的管理水平,保证临床试验的质量。Objective:Retrospectively analyze the common problems with biological samples during drug clinical trials and their causes,and explore measures for pre-risk management.Methods:By summarizing problems with biological samples discovered in quality control from July 2012 to December 2019,analyze causes for these problems and propose measures for pre-risk management.Results:44 problems with biological samples are found in 236 quality control records for 78 clinical trial projects,including:2 related to informed consent for biological samples(2/44,4.55%),16 related to sample collection(16/44,36.36%),8 related to sample processing(8/44,18.18%),16 related to sample storage and transport/transfer(16/44,36.36%),2 related to management of human genetic resources(2/44,4.55%).Possible causes include:personnel responsible for sample management did not follow trial protocol and SOP for sample processing;equipment for sample processing were not calibrated in time;and low compliance on the part of trial subjects.Based on the possible causes,7 risk prevention measures are proposed.Conclusion:Problems with sample collection,storage and transportation are the most common problems of biological sample circulation during clinical trials.Taking pre-risk management measures and whole process quality control will further improve management of biological samples during clinical trials and ensure the quality of clinical trials.

关 键 词：生物样本 风险管理 临床试验 常见问题 前置化管理 

分 类 号：R318[医药卫生—生物医学工程]