研究者发起的临床研究管理体系建设探索  

Exploration on Construction of the Investigator Initiate Trial Management System

作　　者：冯钰 陈仲林[1] 李榕 FENG Yu;CHEN Zhonglin;LI Rong(Clinical Research Unit,Shanghai Chest Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200030,China)

机构地区：[1]上海市胸科医院/上海交通大学医学院附属胸科医院临床研究中心,上海200030

出　　处：《医药导报》2024年第10期1620-1624,共5页Herald of Medicine

基　　金：2022年上海市卫生健康委员会项目资助(202240019);2023年上海申康医院发展中心《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目资助(SHDC2023CRS046)。

摘　　要：目的适应新形势下医学科技创新要求,探索建立具有科学性、规范性和合理性的管理制度和体系,积极推进医疗卫生机构研究者发起的临床研究(IIT)健康发展。方法通过查询文献、政策解读及工作实践,了解目前IIT管理的痛点及难点问题,梳理IIT管理的核心要求及要素,思考完善IIT管理的措施。结果探索IIT管理五大支撑体系建设。职能责任体系,对IIT进行分类分层管理、责权分明;质量监管体系,引入第三方协管机制,填补IIT质量管理三级质控体系的缺漏;经费支撑体系,减免IIT的医院管理费,将IIT承接情况纳入优选SMO年度考评指标;协同创新体系,对外与企业联动,对内各部门协调整合,共同促进IIT的高效率运转;风险预警体系,制定IIT风险评估标准,实时动态监管,强化IIT数据管理,保障IIT数据安全。结论目前IIT管理在国内普遍缺乏足够的重视,且无完备的管理体系框架及实践。通过构建IIT五大体系建设方案,有利于优化流程、提高效率、保障质量、降低风险,对于IIT管理的完善和发展有一定的借鉴意义。Objective To adapt to the requirements of medical technology innovation under the new situation.To explore the establishment of a scientific,standardized,and reasonable management institution and system.It aims to actively promote the development of Investigator Initiate Trials(IITs)in medical and health institutions.Methods By conducting a literature review,policy interpretation,and examing work practices,this study identified the pain points and difficulties in IIT management.It sorted out the core requirements and elements needed for effective IIT management and proposed measures.Results The study proposed the development of five support systems for IIT management.A functional responsibility system for implementing classified and tiered management of IITs with clear delineation of responsibilities and authority;A quality supervision system that introduces a third-party co-management mechanism to fill the gaps of IIT quality management in the three-level quality control system;A fund support system that reduces or waives the hospital management fees for IITs,and incorporate the IIT undertaking into the annual evaluation metrics for optimized SMO;A collaborative innovation system that connect with external enterprises and coordinates internal departments to jointly promote the efficient operation of IITs;A risk early warning system that establishes IIT risk assessment criteria and conducts real-time dynamic supervision,strengthening IIT data management,and ensuring IIT data security.Conclusions Currently,IIT management generally lacks sufficient attention in China,and there is no complete framework or practice.By constructing the five IIT system construction scheme.It is conducive to optimizing the process,improving efficiency,ensuring quality and reducing risk,which has certain reference significance for the improvement and development of IIT management.

关 键 词：医学科技创新 研究者发起的临床研究 管理体系 

分 类 号：R969.4[医药卫生—药理学]