生物医学新技术临床研究的证据质量与证据衔接OA
Evidence Quality and Bridging in Clinical Research on New Biomedical Technologies:Statistical Considerations on Clinical Research in Medical Institutions and Drug/Device Pathway Selection
在《生物医学新技术临床研究和临床转化应用管理条例》《生物医学新技术与药品、医疗器械界定指导原则(暂行)》以及《中华人民共和国药品管理法实施条例》陆续实施的制度背景下,本文以人脐带间充质干细胞药物艾米迈托赛注射液在激素治疗失败的急性移植物抗宿主病中的研究为例,从学术角度探讨生物医学新技术临床研究证据在不同路径选择下的应用边界,及其与药品、医疗器械注册临床证据要求之间的衔接条件,并结合医疗机构内开展相关临床研究时的管理要求,提出提高证据质量与证据衔接价值的统计设计要点.
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.
曹寒;陈晓媛;姚晨
清华大学北京清华长庚医院医学数据科学中心||清华大学临床医学院清华大学北京清华长庚医院临床药械试验中心||清华大学临床医学院清华大学药品监管科学研究院北京大学临床医学高等研究院||海南省真实世界数据研究院
医药卫生
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
clinical research on new biomedical technologiesclinical research in medical institutionsevidence qualityevidence bridgingtarget trial emulationALCOA+eSource
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