浅谈我国医疗器械临床试验中的问题与对策.pdf

中国药事 2015 年 3 月 第 29 卷 第 3 期 229 监督管理 · · 浅谈我国医疗器械临床试验中的问题与对策 马艳彬，李竹，杨牧，梁文，李非 （辽宁省食品药品监督管理局技术审评中心，沈阳 110003） 摘要 目的：针对我国医疗器械临床试验中的问题，提出解决对策，为我国医疗器械临床试验实施者及 管理者提供参考。方法：通过查阅国内外相关法规、文献，结合工作实际进行归纳，总结我国医疗器械 临床试验的现状、医疗器械临床试验相关法规体系建设、临床试验机构及临床试验组织实施过程中存在 的问题，并提出改进建议。结果与结论： 目前我国医疗器械临床试验存在很多问题和不足，医疗器械临 床试验相关法规体系尚不健全，临床试验机构数量及能力不能满足医疗器械临床试验的需求，临床试验 实施者和主要研究者对临床试验组织和实施不到位。建议完善医疗器械临床试验法规体系建设，加强试 验过程的监管，加大法规的宣贯培训力度，提高临床试验实施者及研究者的水平，建立医疗器械临床试 验分期及新产品上市后临床跟踪机制，以保证我国医疗器械临床试验的质量。 关键词： 医疗器械；临床试验管理； 问题分析；改进措施；体系建设；临床跟踪机制 中图分类号：R197 文献标识码：A 文章编号： 1002-7777(2015)03-0229-04 Discussion on Problems in Clinical Trials of Medical Devices in Our Country and Countermeasures Ma Yanbin, Li Zhu, Yang Mu, Liang Wen , Li Fei (Liaoning Food and Drug Administration Technical Evaluation Center, Shenyang 110003, China) Abstract Objective: To study the clinical trial problems of medical devices in China, put forward corresponding solutions, thus provide reference for the clinical trial imptementers and managers. Methods: Based on literature study and actual work experience, an analysis is carried out on clinical trial regulations, organizations and process control. Results and Conclusion: There are many problems and shortcomings in current medical device clinical trials, for example the legal system is not mature, the number and capacity of clinical trial organizations can not meet the needs, and the management of clinical trial by the implementer and primary investigators is deficient. To improve the quality of medical device clinical trials, it is suggested to improve that the legal system, continuously strengthen the supervision of the trial process, increase training efforts, improve the abilities of the investors and investigators, and establish the trial phases and post-market clinical tracking mechanism. Keywords: medical devices; clinical trials regulations; problem analysi