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[欧洲临床研究基础设施网络(ECRIN),一个泛欧洲临床研究基础设施]

[ECRIN (European clinical research infrastructures network), a pan-European infrastructure for clinical research].

作者信息

Demotes-Mainard Jacques

机构信息

Inserm, Institut de Santé Publique, 101 rue de Tolbiac, 75013 Paris.

出版信息

Bull Acad Natl Med. 2010 Dec;194(9):1683-94.

Abstract

Clinical research plays a key role both in the development of innovative health products and in the optimisation of medical strategies, leading to evidence-based practice and healthcare cost containment. ECRIN is a distributed ESFRI-roadmap pan-European infrastructure designed to support multinational clinical research, making Europe a single area for clinical studies, taking advantage of its population size to access patients, and unlocking latent scientific providing services to multinational. Servicing of multinational trials started during the preparatory phase, and ECRIN has applied for ERIC status in 2011. In parallel, ECRIN has also proposed an FP7 integrating activity project to further develop, upgrade and expand the ECRIN infrastructure built up during the past FP6 and FP7 projects, facilitating an efficient organization of clinical research in Europe, with ECRIN developing generic tools and providing generic services for multinational studies, and supporting the construction of pan-European disease-oriented networks that will in turn act as ECRIN users. This organization will improve Europe's attractiveness for industry trials, boost its scientific competitiveness, and result in better healthcare for European citizens. The three medical areas supported in this project (rare diseases, medical devices, and nutrition) will serve as pilots for other biomedical research fields. By creating a single area for clinical research in Europe, this structure will contribute to the implementation of the Europe flagship initiative 2020 'Innovation Union', whose objectives include defragmentation of research and educational capacities, tackling the major societal challenges (starting with healthy aging), and removing barriers to bringing ideas to the market.

摘要

临床研究在创新健康产品的开发以及医疗策略的优化方面都发挥着关键作用,从而实现循证医疗实践并控制医疗成本。欧洲临床研究基础设施网络(ECRIN)是一个分布式的欧洲科学基金会研究基础设施路线图泛欧基础设施,旨在支持跨国临床研究,使欧洲成为临床研究的单一区域,利用其人口规模来招募患者,并为跨国研究挖掘潜在的科学资源并提供服务。跨国试验的服务在筹备阶段就已启动,ECRIN于2011年申请了欧洲研究基础设施合作组织(ERIC)的地位。与此同时,ECRIN还提出了一个“第七框架计划”整合活动项目,以进一步开发、升级和扩展在过去的“第六框架计划”和“第七框架计划”项目中建立的ECRIN基础设施,促进欧洲临床研究的高效组织,ECRIN为跨国研究开发通用工具并提供通用服务,并支持构建泛欧疾病导向网络,而这些网络反过来将成为ECRIN的用户。这种组织架构将提高欧洲对行业试验的吸引力,增强其科学竞争力,并为欧洲公民带来更好的医疗保健。该项目支持的三个医学领域(罕见病、医疗设备和营养)将作为其他生物医学研究领域的试点。通过在欧洲创建一个临床研究的单一区域,这种架构将有助于实施2020年欧洲旗舰计划“创新联盟”,其目标包括整合研究和教育能力、应对重大社会挑战(从健康老龄化开始)以及消除将创意推向市场的障碍。

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