创新医疗器械临床研究方法学框架解读  

Interpretation of the methodological framework of clinical research on innovative medical devices

作　　者：郭琼 冯堃 龙囿霖 林逸飞[1,3] 向瑾[4] 黄进[1,2] 杜亮[1,2,5] GUO Qiong;FENG Kun;LONG Youlin;LIN Yifei;XIANG Jin;HUANG Jin;DU Liang(Medical Device Regulatory Research and Evaluation Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;Chinese Evidence-Based Medicine Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;Precision Medicine Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;Clinical Trials Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;Department of Periodical Press,West China Hospital,Sichuan University,Chengdu,610041,P.R.China)

机构地区：[1]四川大学华西医院医疗器械监管研究与评价中心,成都610041 [2]四川大学华西医院中国循证医学中心,成都610041 [3]四川大学华西医院精准医学研究中心,成都610041 [4]四川大学华西医院临床试验中心,成都610041 [5]四川大学华西医院华西期刊社,成都610041

出　　处：《中国胸心血管外科临床杂志》2022年第7期828-833,共6页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

基　　金：国家自然科学基金(72074161)。

摘　　要：创新医疗器械的上市审批和临床应用,需基于高质量临床研究,证明其可靠性、安全性和有效性。2016年IDEAL(Idea,Development,Exploration,Assessment and Long-term follow-up)协作网在IDEAL框架与推荐的基础上扩展形成了适用于创新医疗器械全生命周期评价的IDEAL-D方法学框架,其包括临床前开发阶段、设计阶段、探索阶段、评价阶段和长期随访阶段共5个阶段。本文旨在基于IDEAL框架与推荐(2019年版),对IDEAL-D框架各阶段评价的目的、内容、设计等进行解读,为创新医疗器械临床研究的设计和开展提供可操作的方法学指导。The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence,proving their reliability,safety and effectiveness.In 2016,the IDEAL(Idea,Development,Exploration,Assessment and Long-term follow-up)collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices.The framework included five stages,namely the preclinical development stage,idea stage,exploration stage,assessment stage and long-term follow-up stage.This paper aims to interpret the study purpose,content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation(2019)to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.

关 键 词：医疗器械 IDEAL框架与推荐 IDEAL-D框架 临床研究 方法学框架 

分 类 号：R197.39[医药卫生—卫生事业管理]