浅谈肿瘤体外诊断试剂的临床试验设计

Clinical scheme design of in vitro tumor diagnostic reagents

肿瘤是严重威胁人类健康的高发病率和高死亡率疾病，肿瘤体外诊断试剂的普及运用提高了肿瘤的诊疗水平。为了充分发挥肿瘤体外诊断试剂在临床使用中的价值，本文将结合《体外诊断试剂质量管理体系考核实施规定（试行）》、《体外诊断试剂临床研究技术指导原则》、《体外诊断试剂注册管理办法（试行）》等法律法规的要求及国内外肿瘤诊断试剂研究进展，浅谈肿瘤体外诊断试剂临床验证的试验设计。（中华检验医学杂志，2014，37：645-648）

Cancer is a serious threat to human health with high morbidity and high mortality , using vitro tumor diagnostic reagents can improve the level of diagnosis and treatment.In order to develop the value of in vitro tumor diagnostic reagents in clinical use , this article would analyze “in vitro diagnostic reagents technical guidelines for clinical research” ,“in vitro diagnostic reagents registration” and other laws and regulations ,as well as the development of research in domestic and foreign.To discuss the clinical scheme design and development trend of in vitro tumor diagnostic reagents.