体外诊断试剂临床试验的质量控制

随着体外诊断技术的发展和体外诊断试剂生产企业研发水平的不断提高，体外诊断试剂临床试验日益增多。部分体外诊断试剂在获得食品药品监督管理部门注册许可进入临床使用前，必须要经过临床试验，但体外诊断试剂临床试验在实施过程中存在较多质量问题。本文从体外诊断试剂临床试验项目预试验实施、知情同意、方案入排标准设计及执行、生物样本管理、伴随诊断试剂盒肿瘤疗效评价数据收集、临床试验记录和报告等临床试验项目实施关键点，分析了体外诊断试剂临床试验质量控制中存在的问题，为体外诊断试剂临床试验的规范化实施提供参考。

Quality Control of In Vitro Diagnostic Clinical Trails

With the development of in vitro diagnostic (IVD) technology and the continuous improvement of the research level of IVD manufacturing enterprises, IVD clinical trials are increasing. Before getting the approval of clinical use from the Food and Drug Administration, some IVD clinical trials should be conducted. However, there are many quality problems in the IVD clinical trial experiment. To analyze the existing problems in the quality control of IVD clinical trials, the key points for quality control of clinical trial of IVD were summarized, including preliminary tests of clinical trials, information consent, design and implementation of inclusion and exclusion criteria, biological sample management, source data of response evaluation from retrospective companion diagnostic IVD clinical trials, and clinical trial records and reports. It would provide references for the standardization of IVD clinical trials.