中国食品药品监管Issue(3)：52-59,8.DOI:10.3969/j.issn.1673-5390.2026.03.005
医疗器械临床试验不良事件报告的实践困境与对策研究
Adverse Event Reporting in Medical Device Clinical Trials:Challenges and Countermeasures
杨千粟 1白楠 1李珍珍 2曹江 1周吉银3
作者信息
- 1. 中国人民解放军总医院医疗保障中心||中国人民解放军总医院第一医学中心伦理办公室
- 2. 中国人民解放军总医院医疗保障中心
- 3. 陆军军医大学第二附属医院临床医学研究中心
- 折叠
摘要
Abstract
The monitoring and reporting of adverse event(AE)in medical device clinical trials play a crucial role in evaluating the safety of investigational devices.This study systematically reviews relevant domestic and international regulations and literature,and draws on the authors'hands-on experience in clinical trial management to explore the key challenges currently affecting AE reporting in China.These challenges include:over-reliance on investigators as the sole authority for causality assessment;insufficient anticipation and consideration of potential AEs during trial design;the limited role of ethics committees in protecting the rights and interests of research participants;the lack of clear policy support for AE follow-up and long-term participant protection;and inadequacies in safety-related oversight and training mechanisms.In response,this study proposes a series of targeted optimization measures aimed at enhancing the scientific rigor and ethical standards of medical device clinical trials and ensuring the safety of medical device use by research participants.关键词
医疗器械/临床试验/不良事件/严重不良事件/伦理审查Key words
medical devices/clinical trials/adverse events/serious adverse events/ethical review分类
医药卫生引用本文复制引用
杨千粟,白楠,李珍珍,曹江,周吉银..医疗器械临床试验不良事件报告的实践困境与对策研究[J].中国食品药品监管,2026,(3):52-59,8.
