肿瘤药物临床试验质控检查问题回顾性分析

Retrospective Analysis on Quality Control Inspection in Clinical Trials of Tumor Drugs

目的提高肿瘤药物临床试验质量。方法收集2019年医院药物临床试验机构的肿瘤药物临床试验质控检查结果,根据《药物临床试验数据现场核查要点》标准对发现的不合格问题进行归类分析。结果2019年医院药物临床试验完成质控检查68次,发现存在违反核查要点的不合格问题7个168项,其中临床试验过程记录及临床检查、化验等数据的溯源问题最多(84项,50.00%),其次是临床试验条件和合规性问题(28项,16.67%),再次为受试者筛选/入组相关数据链的完整性问题(22项,13.10%)。结论该院肿瘤药物临床试验质控检查中发现,临床试验数据溯源、数据链的完整性、临床试验条件和合规性等方面存在一定问题,应通过完善试验设计,加强人员培训,强化各级质控,以确保试验质量及受试者权益。

Objective To improve the quality of clinical trials of tumor drugs.Methods The results of quality control inspections of clinical trials of tumor drugs in the hospital in 2019 were collected;the unqualified problems were classified and analyzed according to the standard of″Key Points of On-Site Inspection of Clinical Trials of Drugs″.Results In 2019,68 quality control inspections on the clinical trials of drugs were completed in the hospital,and 7 unqualified problems with 168 items violating the″Key Points of Inspection″were found.Among them,the traceability of clinical trial process records,clinical inspections,and laboratory data were the most(84 items,50.00%),followed by clinical trial conditions and compliance issues(28 items,16.67%),then the completeness of the data link related to the screening/entry of subjects(22 items,13.10%).Conclusion It is found that there are many problems in the traceability of test process records and inspection data,the integrity of data chain related to screening/enrollment,clinical trial conditions and compliance in the inspections of clinical trials of tumor drugs in the hospital.Through improving the test design,strengthening personnel training and education,strengthening quality control at all levels,to ensure the test quality and the rights and interests of the subjects.