临床试验中违背方案问题的分析与建议

Analysis and Suggestion on Issues of Protocol Violation in Clinical Trials

通过对某三甲医院近6年受理的293份违背方案报告进行分类统计,从违背类型、严重程度、责任归属、对受试者及试验数据的影响等方面进行归纳和总结,剖析违背发生的原因,并提出建议。结果显示,最常见的违背方案类型为实验室检验/检查缺失,其次为不符合入排标准、给予错误的治疗或错误的药量等。责任主体主要为研究者,其次为监查员,受试者依从性差也是发生违背的原因之一。因此,违背方案是临床试验过程中不可避免的问题。加强研究者GCP培训,提高监查员工作质量,加强相关职能部门的有效协作和监管力度,以及保证受试者依从性等都是减少违背方案的有效措施。伦理委员会应加大违背方案的审查力度和监督,切实保障受试者利益和临床试验质量。

Based on the classified statistics of 293 violation protocol reports received by a third-grade hospital in the past 6 years,this paper analyzed and summarized the reasons for the violation from the aspects of violation type,severity,attribution of responsibility,impact on subjects and test data,and put forward feasible suggestions.The results showed that the most common types of protocol violation were missing laboratory tests/inspections,followed by failure to meet inclusion/exclusion criteria,giving wrong treatment or wrong dosage,etc.The main bodies of responsibility were researchers,followed by the inspectors.Subjects’poor compliance was also one of the reasons for the violation.Therefore,protocol violation is an inevitable problem in clinical trials.Strengthening GCP training for researchers,improving the quality of inspectors’work,enhancing effective collaboration and supervision of relevant functional departments,and ensuring subject compliance are effective measures to reduce violations.The ethics committee should intensify the review and supervision of protocol violations to effectively protect the benefit of the subjects and the quality of clinical trials.