药物和医疗器械临床研究评价平台建设的思考  

Construction and exploration of clinical research evaluation platform for drugs and medical devices

作　　者：杨雪[1] 李建民[2] 赵楠[1] 刘松江[2] YANG Xue;LI Jianmin;ZHAO Nan;LIU Songjiang(National Traditional Chinese Medicine Clinical Research Base Project office,First Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin 150000,China;First Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin 150000,China)

机构地区：[1]黑龙江中医药大学附属第一医院,国家中医临床研究基地项目办公室,黑龙江哈尔滨150000 [2]黑龙江中医药大学附属第一医院,黑龙江哈尔滨150000

出　　处：《药物评价研究》2020年第10期2138-2142,共5页Drug Evaluation Research

基　　金：黑龙江省博士后基金项目(LBH-Z16201);黑龙江中医药大学科研基金项目(201829)。

摘　　要：2018年末,国家中医药管理局在《国家中医临床研究基地业务建设方案(专家论证编写提纲)》中首次要求各个国家中医临床研究基地单位建立"药物和医疗器械的临床研究评价平台"。从该平台的职能、建设原则、目标、组织形式、工作流程、内部运行机制等方面作为切入点,结合有关政策法规及文献研究结果以及多年的临床评价工作经验,对如何建设药物和医疗器械研究评价平台,保障平台各项职能有效落实,最大化地发挥平台的作用,整合基地现有科研平台,实现资源的优化、共享等提出了可行的建议,以期为药物和医疗器械的临床评价科研平台的建设提供参考。At the end of 2018, the State Administration of Traditional Chinese Medicine issued the "The Business Construction Plans for National Traditional Chinese Medicine(TCM) Clinical Research Base(Experts’ Compilation Outline)", in which the national TCM clinical research base units was requested for the first time to establish "Clinical Research Evaluation Platform for Drugs and Medical Devices".The author starts from the aspects of platform functions, construction principles, goals, organizational forms,workflows, internal operating mechanisms, etc.and combines years of base work experience, national policies and regulations, and literature research results.Specific suggestions were made on how to establish a research and evaluation platform for drugs and medical devices, ensure the effective implementation of various functions of the platform, maximize the role of the platform,integrate the existing scientific research platform at the base, and optimize the sharing of resources,in order to provide reference for the construction of the base scientific research platform.To our best knowledge, no research on the platform has been retrieved,since the publication of the document.

关 键 词：国家中医临床研究基地 科研平台 临床试验 药物研发 医疗器械 临床评价 

分 类 号：R969[医药卫生—药理学] R955[医药卫生—药学]