中国食品药品监管Issue(5)：38-51,14.DOI:10.3969/j.issn.1673-5390.2026.05.002
生物医学新技术临床研究的证据质量与证据衔接
Evidence Quality and Bridging in Clinical Research on New Biomedical Technologies:Statistical Considerations on Clinical Research in Medical Institutions and Drug/Device Pathway Selection
摘要
Abstract
Against the institutional backdrop of the successive implementation of the Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies,the Interim Guidelines for the Definition of New Biomedical Technologies,Drugs and Medical Devices,and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China,this paper takes the study of Amimatoside Injection,an umbilical cord mesenchymal stem cell therapy,for steroid-refractory acute graft-versus-host disease(aGVHD)as an example.From an academic perspective,the paper explores the application boundaries of clinical research evidence for novel biomedical technologies under different regulatory pathway selections,as well as the bridging convergence conditions between such evidence and the clinical evidence requirements for drug and medical device registration.Furthermore,in light of the management requirements for conducting relevant clinical research in medical institutions,the study proposes statistical design considerations aimed at improving evidence quality and enhancing the value of evidence bridging.关键词
生物医学新技术临床研究/医疗机构临床研究/证据质量/证据衔接/目标试验模拟/ALCOA+/电子源数据Key words
clinical research on new biomedical technologies/clinical research in medical institutions/evidence quality/evidence bridging/target trial emulation/ALCOA+/eSource分类
医药卫生引用本文复制引用
曹寒,陈晓媛,姚晨..生物医学新技术临床研究的证据质量与证据衔接[J].中国食品药品监管,2026,(5):38-51,14.基金项目
昌平实验室资助课题(2023C-10-01) （2023C-10-01）
