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| 从科研监管视角探析研究者发起临床研究存在的问题与对策 |
| Problem exploration and measures on the investigator initiated trial from the perspective of scientific research supervision |
| 投稿时间：2018-10-15 修订日期：2018-11-16 |
| DOI：10.3760/cma.j.issn.1006-1924.2019.05.005 |
| 中文关键词: 科研监管 研究者发起的临床研究 问题 对策 |
| 英文关键词: Scientific research supervision Investigator initiated trial(IIT) Problem Countermeasures |
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| 摘要点击次数: 1082 |
| 中文摘要: |
| 目的 通过分析临床研究（IIT）项目存在的问题，提出相应对策，为规范临床科研项目管理提供借鉴。方法 通过文献研究、临床研究项目数据统计分析、对比研究及归纳总结等方法 对医院IIT项目科研监管中所存在的4类问题进行剖析。包括科研监管职能、方法指南和诊疗技术规范、科研设计与立项审评、研究经费、医学伦理委员会、生物样本库建设、监管冲突等方面存在问题。结果 提出了建立健全IIT项目科研监管组织；引入IIT项目方案指导修改组，强化学术审查；强化风险管理，保障医疗安全；开展IIT培训；建立IIT管理数据库信息系统；构建医院生物样本库综合集成开发多点应用模式等6项针对性管理改善措施。结论 建立医院IIT科研监管体系、管理模式、技术标准体系，对规范开展临床研究保证研究质量、有效指导医院临床研究工作至关重要。 |
| 英文摘要: |
| Objective By analyzing the problems existed in the Investigator Initiated Trial(IIT), this article put forward the corresponding countermeasures and therefore provides reference for the standardization of clinical research project management. Methods Four types of problems identified in the supervision of hospital IIT projects are analyzed according to literature review, data analysis of clinical research project， comparative study and summary. Identified problems are existed in the following aspects: scientific research supervision function, research method guidelines, technical specification of the diagnosis and treatment, scientific research design and project approval review, research funds, medical ethics committee, construction of Biobank and Regulation Conflicts.Results This article put forward 6 countermeasures for improvement: establishing and perfect IIT project scientific research supervision entity, bring in the IIT project steering group to strengthen the scientific review; Strengthen risk management to ensure medical safety, carry out IIT training, establish IIT management database information system, build a comprehensive integrated development multi point application model of hospital BioBank. Conclusions The establishment of the hospital's IIT scientific research supervision system, management mode and technical standard system is of great importance to standardize clinical research，ensure research quality and guide the clinical research work of the hospital effectively. |
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