体外诊断试剂临床试验存在的问题与分析  

Problems and analysis of clinical trials of in vitro diagnostic reagents

作　　者：吴丹 李平 鄢峰 WU Dan;LI Ping;YAN Feng(Jiangxi Provincial Drug Certification and Evaluation Center,Nanchang,Jiangxi,China,330046)

机构地区：[1]江西省药品认证审评中心,江西南昌330046

出　　处：《分子诊断与治疗杂志》2023年第5期905-908,共4页Journal of Molecular Diagnostics and Therapy

摘　　要：体外诊断试剂(IVD)临床试验获得的数据应当真实和准确,以保证该产品的安全风险和临床性能得到充分评价,而临床试验监督检查是评估临床试验过程的合规性和临床数据的真实性的监管手段。本文从临床试验准备、伦理审查、临床试验实施三个方面对监督检查发现的典型问题进行分析,探究问题产生的深层次原因,并提出改进措施,以规范临床研究。The data obtained from clinical trials of in vitro diagnostic reagents(IVD)should be true and accurate to ensure that the safety risks and clinical performance of the product are fully evaluated.Clinical trial supervision and inspection is a regulatory means to evaluate the compliance of clinical trial process and the authenticity of clinical data.This article analyzes the typical problems found in the supervision and inspection from three aspects:clinical trial preparation,ethical review,and clinical trial implementation,explores the deep causes of the problems,and proposes improvement measures to standardize the clinical research.

关 键 词：体外诊断试剂 临床试验 监督检查 

分 类 号：R95[医药卫生—药学]