某机构药物临床试验数据核查发现问题及改进措施

目的：对某机构药物临床试验项目数据核查发现的问题进行系统分析,剖析项目开展过程中发现的问题的原因,提出意见和建议,以提高临床试验质量,为同行提出参考。方法：收集某机构16个项目数据核查发现的问题,对照"药物临床试验数据现场核查要点"进行分类,对16个项目数据核查发现的问题进行分析。结果：11个项目存在违反数据核查要点的问题53项,其中在受试者的筛选/入组相关数据链的完整性方面存在问题7项（占13.21%）;在知情同意书的签署与试验过程的真实完整性方面存在问题2项（占3.77%）;在临床试验过程记录及临床检查、化验等数据的溯源方面存在问题29项（占54.72%）;在CRF中违背方案和严重不良事件例数等关键数据方面存在问题2项（占3.77%）;在试验用药品管理过程与记录方面存在问题9项（占16.98%）;在临床试验的生物样本采集、保存、运送与交接记录方面存在问题1项（占1.89%）;在原始数据、统计分析和总结报告与锁定的数据库一致性方面存在问题3项（占5.66%）。结论：本次分析显示,某机构在临床试验过程记录及临床检查、化验等数据的溯源方面、受试者的筛选/入组相关数据链的完整性方面和药品管理方面存在问题较多,加强对临床试验的质量控制,确保临床试验质量,保护受试者的权益。

Problems and countermeasures for data verification of drug clinical trial

OBJECTIVE To systematically analyze problems found during the verification of drug clinical trials from an institution,to analyze the causes of the problems,and provide opinions and suggestions,improve the quality of drug clinical trials,and put forward a reference for the peers.METHODS Totally 16 items were collected from the verification data of drug clinical trials from an institution,then classified by the "Key Points for On-Site Verification of Drug Clinical Trial Data",and then analyzed.RESULTS Totally 53 problems were identified in 11 items,including 7 (13.21%) with respect to the integrity of data chain related to participant screening/inclusion; 2 (3.77%) with respect to the authenticity and integrity of the written informed consent; 29 (54.72%) with regard to the recording of clinical trial process and data traceability of clinical examinations and laboratory tests; 2 (3.77%) with regard to the data of number of cases violating the protocol and cases with severe adverse events; 9 (16.98%) with respect to the management and recording of investigational drugs; 1 (1.89%) with respect to the collection,storage,delivery,and reception records of biological samples;3 (5.66%) with respect to the consistency of original data,statistical analysis and summary report,and finalized database.CONCLUSION Problems identified via this investigation mainly include the recording of clinical trial process and data traceability of clinical examinations and laboratory tests,the integrity of data chain related to participant screening/inclusion,management and recording of investigational drugs.The drug clinical trial institution should strengthen the quality control of clinical trials to ensure the quality of clinical trials and protect the rights and interests of the participants.