【摘要】 目的:分析体外诊断试剂临床试验中的质量问题,研究制定其质量保证提升措施。方法:汇总医院体外诊断试剂临床试验项目自查发现的质量问题并进行分类,利用帕累托图对其进行统计、分类和分析,确定临床试验中存在问题的主要类型,应用鱼骨图进行根因分析,从试验设计、试验实施和数据总结与报告环节制定质量提高措施。结果:在选取的2013-2019年医院承接体外诊断试剂临床试验的4 235份样本中,共发现质量问题119个,归属10项问题类型,其主要因素为试验记录、试验试剂、方案执行、申报资料、伦理审查及文件和原始记录6项,次要因素为试验样本1项,一般因素有试验人员、知情同意和统计分析3项,应用鱼骨图分析影响试验质量原因,针对临床试验的3个主要环节制定17条质量提升措施。结论:应用帕累托图和鱼骨图分析方法,可梳理出常见的体外诊断试剂临床试验质量问题和原因,制定出体外诊断试剂临床试验质量保证措施,从源头上确保体外诊断试剂临床试验质量。更多还原

【Abstract】 Objective: To analyze the quality problems of in vitro diagnostic(IVD) reagents in clinical trials, and study and formulate the measures of enhancing quality assurance of these reagents. Methods: Summarized and classified the quality problems which were found in self-inspection of the clinical trial projects of IVD reagents of hospital, and used the Pareto chart to count as statistics method, classify and analyze, and confirmed the main types of existing problems in clinical trials, and used the fishbone diagram for root cause analysis. And then, formulated quality improvement measures from trial design, trial implementation, data summary and reporting. Results: In the selected 4,235 samples of clinical trials of IVD reagents who undertaken in hospital from 2013 to 2019, a total of 119 quality problems were found and were summarized to 10 problem types, and the main factors of these problems were 6 items included trial records, trial reagents, program implementation, application materials, ethical review and documents, and original records. And the secondary factor was 1 item test samples, and the general factors included research staff, inform consent and statistical analysis. The fishbone diagram was applied to analyze the reasons that affect the quality of the trials, and then 17 quality improvement measures were formulated for the 3 main procedures of clinical trials. Conclusion: The application of Pareto chart and fishbone diagram analysis can sort out common quality problems and reasons of IVD reagents of clinical trials, and formulate quality assurance measures for them, and ensure the quality of IVD reagents of clinical trials from the source.更多还原