儿童药物临床试验项目质控中的常见问题与对策

Common Problems and Countermeasures in Quality Control of Pediatric Clinical Trials

目的:在药物临床试验中,应保障儿童受试者的合法权益和生命安全,确保试验记录和报告数据准确、完整、可信。方法:收集无锡市儿童医院药物临床试验机构、自2018年以来所有项目的质控报告,将报告中记录的问题进行分类汇总,分析问题原因,提出解决方法。结果:儿童药物临床试验在知情同意过程、试验方案执行、试验记录、原始资料收集、检查报告单评判等几方面存在问题较多,临床试验机构、伦理委员会、研究者要各司其职,注重细节,将质量管理贯穿始终。结论:在儿童药物临床试验中,存在有别于成人试验的特殊性,应对试验质量进行全过程把关,尽可能避免试验各环节出现的失误和差错。

Objective:To guarantee the legitimate rights,interests and life safety of children subjects,and to ensure the accuracy,completeness and reliability of the test records and reports.Methods:The quality control reports were collected from all the projects in the drug clinical trial institution of Wuxi Children’s Hospital since 2018.Problems recorded in the reports were classified and summarizes.The causes of the problems were analyzes for solutions.Results:There were many problems in the informed consent process,the implementation of the trial plan,the trial records,the collection of original data and the evaluation of the inspection reports in the clinical trials of children’s drugs.The GCP office,the ethics committee and the investigators should perform their duties,pay attention to details,and carry out quality management throughout.Conclusions:Children are particular in physiological,psychological and cognitive aspects,and there are many differences in clinical trials between adult and children.The quality management should be done throughout the course of trial implementation to avoid errors as much as possible.