文章摘要
医疗器械临床试验数据核查的常见问题及思考
Common issues and thoughts on clinical trial data inspection of medical device
投稿时间:2020-01-17  修订日期:2020-05-06
DOI:
中文关键词: 药物临床试验  数据核查  常见问题
英文关键词: Medical device  Data Inspection  Common issues
基金项目:北京医药临床研发平台(CRO平台):北京生物医药产业跨越发展工程(G20工程)
作者单位E-mail
王瓅珏 北京大学人民医院科研处 wljamanda@163.com 
谢振伟 北京大学人民医院科研处  
范华莹 北京大学人民医院科研处  
郭丹杰 北京大学人民医院科研处  
饶慧瑛 北京大学人民医院科研处  
韩娜 北京大学人民医院科研处  
王天兵 北京大学人民医院科研处  
摘要点击次数: 32
中文摘要:
      目的:医疗器械临床试验数据结果的真实性和准确性是试验产品有效、安全的可靠保障。本文拟通过分析我院既往医疗器械临床试验数据核查中出现的问题,总结经验并提出解决措施。方法:回顾性分析自2016年《医疗器械临床试验现场检查要点》颁布后,我院医疗器械临床试验的数据核查情况,对核查的常见问题进行梳理与归纳。结果:我院共接受4个医疗器械临床试验的数据核查,发现问题20项。这些问题涉及临床试验条件与合规性、临床试验部分、临床试验数据管理、受试产品的管理等方面。结论:应根据医疗器械临床试验的特殊性,更有针对性的进行质控与培训,加强信息化与中心化管理,从而保证医疗器械临床试验数据真实可靠、试验结果客观可信。
英文摘要:
      Objective: The authenticity and accuracy of medical device related clinical trial data is the essential assurance of efficacy and safety of tested products. This article analyzed issues identified during previous data inspection of medical device clinical trials in our hospital, summarized experience and learnings, and proposed solutions. Method: Retrospective analysis of issues identified during previous data inspection of medical device clinical trials in our hospital, since the implementation of Key points of on-site inspection of medical device clinical trials in 2016. Result: There are a total of 4 medical device trial data inspections took place in our hospital, with 20 issues identified relating to clinical trial conditions, compliance, clinical trial operation, management of clinical trial data, management of test products, etc. Conclusion: In respect to the particularity of medical device clinical trials, we should have more specific quality control and training, enhance the informatization and centralization of management, to ensure a authentic and arrurate clinical trial data, and reliable clinical trial result.
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