本研究旨在探讨申办者在医疗器械临床试验中构建文件质量控制体系的必要性,并介绍基于量化评价的全面质量控制体系。该体系以国内相关规范为指导,涵盖研究中心和申办者文件夹的质控,通过评分机制客观评估文件质量,并结合质控员–监查员...本研究旨在探讨申办者在医疗器械临床试验中构建文件质量控制体系的必要性,并介绍基于量化评价的全面质量控制体系。该体系以国内相关规范为指导,涵盖研究中心和申办者文件夹的质控,通过评分机制客观评估文件质量,并结合质控员–监查员–研究者反馈环路以及质控员–质控体系负责人–质控体系环路,实现问题发现、整改和持续改进。超过85%的临床试验质控评分呈现出逐次上升的趋势,质控中问题的发生率也呈现出下降趋势。该体系有效提升了临床试验文件质量,为申办者提供了标准化、可操作的质控流程,为提升我国医疗器械临床试验整体管理水平提供了参考。This study aims to investigate the necessity for sponsors to establish a quality control system for clinical trial documentation in medical device clinical trials and to introduce a quantitatively assessed total quality control system. Guided by domestic regulations, this system encompasses the quality control of both investigator and sponsor Trial Master File (TMF). TMF quality can be assessed objectively through a scoring mechanism, which is integrated with a feedback loop involving quality controllers, monitors, and investigators, as well as a loop between quality controllers, quality control management, and the quality control system, to facilitate problem identification, rectification, and continuous improvement. Over 85% of clinical trial quality control scores showed a trend of successive increase, and the incidence of issues identified during quality control also demonstrated a decreasing trend. The system effectively enhances the quality of clinical trial documentation, providing sponsors with a standardized and operational quality control process, and serves as a reference for improving the overall management level of medical device clinical trials in our country.展开更多
目的分析国内医疗器械临床试验项目暂停终止的具体原因。基于分析结果为参与试验的各方提出参考建议和完善措施。方法采用资料收集法收集国内医疗器械临床试验样本,走访多家医疗机构,对于状态处于暂停或终止的项目,采取现场采访研究团...目的分析国内医疗器械临床试验项目暂停终止的具体原因。基于分析结果为参与试验的各方提出参考建议和完善措施。方法采用资料收集法收集国内医疗器械临床试验样本,走访多家医疗机构,对于状态处于暂停或终止的项目,采取现场采访研究团体和临床试验机构办工作人员、查阅研究者文件夹中存放的“项目暂停/终止函”、电话咨询项目的临床监察员(clinical research associate,CRA)等方式来获知项目暂停或终止的具体原因;走访一家合同研究组织(contract research organization,CRO)商业公司,对于项目状态为暂停或终止的项目,采取现场访谈或电话咨询项目经理、CRA中办方相关人员等方式获知项目暂停或终止的具体原因。通过描述性分析法总结暂停终止原因及其暂停终止率。结果统计分析得到我国的医疗器械临床试验暂停终止率为17.30%,其中在医疗机构收集到的样本中暂停终止率为16.04%,在CRO公司收集到的医疗器械临床试验暂停终止率为21.30%。导致国内医疗器械临床试验总体暂停终止的原因包括申办方策略调整、医疗机构或研究团队原因、产品或方案设计缺陷、改用同类产品数据注册、试验结果相关、第三方服务商相关、其他原因、安全性相关、疫情原因、法规更新、知情困难。结论导致国内医疗器械临床试验项目暂停终止的原因具有复杂性和多样性,统计分析得到我国的医疗器械临床试验暂停终止率为17.30%。展开更多
文摘本研究旨在探讨申办者在医疗器械临床试验中构建文件质量控制体系的必要性,并介绍基于量化评价的全面质量控制体系。该体系以国内相关规范为指导,涵盖研究中心和申办者文件夹的质控,通过评分机制客观评估文件质量,并结合质控员–监查员–研究者反馈环路以及质控员–质控体系负责人–质控体系环路,实现问题发现、整改和持续改进。超过85%的临床试验质控评分呈现出逐次上升的趋势,质控中问题的发生率也呈现出下降趋势。该体系有效提升了临床试验文件质量,为申办者提供了标准化、可操作的质控流程,为提升我国医疗器械临床试验整体管理水平提供了参考。This study aims to investigate the necessity for sponsors to establish a quality control system for clinical trial documentation in medical device clinical trials and to introduce a quantitatively assessed total quality control system. Guided by domestic regulations, this system encompasses the quality control of both investigator and sponsor Trial Master File (TMF). TMF quality can be assessed objectively through a scoring mechanism, which is integrated with a feedback loop involving quality controllers, monitors, and investigators, as well as a loop between quality controllers, quality control management, and the quality control system, to facilitate problem identification, rectification, and continuous improvement. Over 85% of clinical trial quality control scores showed a trend of successive increase, and the incidence of issues identified during quality control also demonstrated a decreasing trend. The system effectively enhances the quality of clinical trial documentation, providing sponsors with a standardized and operational quality control process, and serves as a reference for improving the overall management level of medical device clinical trials in our country.
文摘目的分析国内医疗器械临床试验项目暂停终止的具体原因。基于分析结果为参与试验的各方提出参考建议和完善措施。方法采用资料收集法收集国内医疗器械临床试验样本,走访多家医疗机构,对于状态处于暂停或终止的项目,采取现场采访研究团体和临床试验机构办工作人员、查阅研究者文件夹中存放的“项目暂停/终止函”、电话咨询项目的临床监察员(clinical research associate,CRA)等方式来获知项目暂停或终止的具体原因;走访一家合同研究组织(contract research organization,CRO)商业公司,对于项目状态为暂停或终止的项目,采取现场访谈或电话咨询项目经理、CRA中办方相关人员等方式获知项目暂停或终止的具体原因。通过描述性分析法总结暂停终止原因及其暂停终止率。结果统计分析得到我国的医疗器械临床试验暂停终止率为17.30%,其中在医疗机构收集到的样本中暂停终止率为16.04%,在CRO公司收集到的医疗器械临床试验暂停终止率为21.30%。导致国内医疗器械临床试验总体暂停终止的原因包括申办方策略调整、医疗机构或研究团队原因、产品或方案设计缺陷、改用同类产品数据注册、试验结果相关、第三方服务商相关、其他原因、安全性相关、疫情原因、法规更新、知情困难。结论导致国内医疗器械临床试验项目暂停终止的原因具有复杂性和多样性,统计分析得到我国的医疗器械临床试验暂停终止率为17.30%。
