METHODS Team, Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France; Center for Clinical Epidemiology, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 Place du Parvis Notre Dame, 75004 Paris, France.
METHODS Team, Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France; Center for Clinical Epidemiology, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), 1 Place du Parvis Notre Dame, 75004 Paris, France; Department of Epidemiology, Columbia University Mailman School of Public Health, 22 W 168th St, New York, NY, USA.
J Clin Epidemiol. 2020 Aug;124:139-148. doi: 10.1016/j.jclinepi.2020.04.021. Epub 2020 May 5.
The current clinical research system relies on a "one-off" project-by-project model involving a costly and time-wasting permanent construction and deconstruction of the research infrastructure. We propose a new model of research relying on collaborative principles: the COllaborative Open Platform (COOP') e-cohort.
The COOP' e-cohort aims at building a large community of patients willing to participate in research by contributing to the generation of a large database of patient-reported data, passively enriched, at the individual level, by linkage with routinely collected care and/or medico-administrative data. Approved teams can use the platform and benefit from already enrolled participants or collected data or add new online questionnaires to perform observational or interventional studies to answer a broad range of research questions.
The Community of Patients for Research (ComPaRe) is a proof-of-concept COOP' e-cohort in the field of chronic conditions that was launched in 2017. As of April 2020, 36,000 patients have joined the project and contributed to more than 4 million data points. Patient-reported data will be enriched by linkage with the French national health system databases and with hospital data for patients receiving care in the Paris region. Since 2017, 150 researchers have used the platform for research projects. Three clinical trials nested in ComPaRe have been funded.
By moving from myriad independent studies to a large collaborative infrastructure of research, COOP' e-cohorts will accelerate the research process by avoiding the redundancy of many steps common to all research projects and by limiting waste of research.
当前的临床研究系统依赖于“一次性”的项目式模型，涉及到昂贵且耗时的研究基础设施的永久性构建和拆除。我们提出了一种新的研究模式，该模式基于协作原则：即协作开放式平台（COOP'）电子队列。
COOP'电子队列旨在建立一个庞大的患者社区，这些患者愿意通过贡献患者报告数据的大型数据库来参与研究，这些数据在个体层面上通过与常规收集的护理和/或医疗管理数据的链接进行被动丰富。经过批准的团队可以使用该平台并从已经注册的参与者或已收集的数据中受益，或添加新的在线问卷来进行观察性或干预性研究，以回答广泛的研究问题。
患者参与研究共同体（ComPaRe）是一个在慢性病领域的 COOP'电子队列的概念验证项目，于 2017 年启动。截至 2020 年 4 月，已有 36000 名患者加入该项目，并贡献了超过 400 万个数据点。患者报告的数据将通过与法国国家卫生系统数据库以及巴黎地区接受护理的患者的医院数据的链接进行丰富。自 2017 年以来，已有 150 名研究人员使用该平台进行研究项目。ComPaRe 中嵌套了三个临床试验已获得资助。
通过从无数的独立研究转向一个大型的协作研究基础设施，COOP'电子队列将通过避免所有研究项目共有的许多步骤的冗余并限制研究的浪费来加速研究过程。
