提高研究者发起的临床研究质量的策略和方法  

Strategies and measures for improving the quality of Investigator-Initiated Trials

作　　者：张卿 张力 Zhang Qing;Zhang Li(Clinical Research Center,Tongji Hospital of Tongji University,Shanghai 200065,China)

机构地区：[1]同济大学附属同济医院临床研究中心,上海200065

出　　处：《中华医学科研管理杂志》2022年第1期16-19,共4页Chinese Journal of Medical Science Research Management

基　　金：国家自然科学基金委员会专项项目(J2024002);上海市卫生健康委员会政策研究课题(2020HP15);上海申康医院发展中心临床管理优化项目(SHDC12019637)。

摘　　要：目的探讨医疗卫生机构(以下简称"机构")如何提高研究者发起的临床研究(Investigator-Initiated Trials,IIT)的质量。方法通过检索文献并结合工作实践,针对目前IIT存在的问题,提出确保临床研究质量的策略和具体方法。结果机构应着重从以下4个方面入手,以保障和提升IIT质量:设置专门的IIT管理机构,组建中心化管理体系;组织研究者进行系统性的法规、临床研究方法学培训;建立有效的质控体系和质量评估指标;采用电子信息化系统和信息化管理平台,完善管理。结论机构加强对IIT的规范化管理,是提高IIT研究质量的有效策略。Objective To explored how medical and health institutions can improve the quality of Investigator-Initiated Trials(IIT).Methods Strategies and measures were proposed to ensure the quality of IIT based on the combination of related literature review and IIT management experiences analysis.Results Institutions can carry out following measurements to improve the quality of IIT,which include setting up tailored IIT management department,establish centralized management system;conducting systematic regulatory and clinical research methodology trainings;develop effective quality control system and quality assessment index,applying electronic information system and platform to optimize the management.Conclusions Strengthen the standardized management is an effective strategy to improve the quality of IIT in medical and health institutions.

关 键 词：研究者发起的临床研究 质量评估指标 信息化管理 

分 类 号：R197.323[医药卫生—卫生事业管理]