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国际临床研究数据生态系统:从数据标准化到联合分析。

International Clinical Research Data Ecosystem: From Data Standardization to Federated Analysis.

作者信息

Rinaldi Eugenia, Dellacasa Chiara, Puskaric Miroslav, Osmo Thomas, Gorska Anna, Stellmach Caroline

机构信息

Berlin Institute of Health at Charité-Universitaetsmedizin Berlin, Germany.

Cineca Consorzio Interuniversitario, Bologna, Italy.

出版信息

Stud Health Technol Inform. 2023 Oct 20;309:133-134. doi: 10.3233/SHTI230757.

DOI:10.3233/SHTI230757
PMID:37869823
Abstract

Within the HORIZON 2020 project ORCHESTRA, patient data from numerous clinical studies in Europe related to COVID-19 were harmonized to create new knowledge on the disease. In this article, we describe the ecosystem that was established for the management of data collected and contributed by project partners. Study protocols elements were mapped to interoperability standards to establish a common terminology. That served as the basis of identifying common concepts used across several studies. Harmonized data were used to perform analysis directly on a central database and also through federated analysis when data was not permitted to leave the local server(s). This ecosystem facilitates the answering of research questions and generation of new knowledge available for the scientific community.

摘要

在“地平线2020”项目“ORCHESTRA”中,来自欧洲众多与新冠疫情相关临床研究的患者数据被整合,以获取有关该疾病的新知识。在本文中,我们描述了为管理项目合作伙伴收集和提供的数据而建立的生态系统。研究方案要素被映射到互操作性标准,以建立通用术语。这为识别多项研究中使用的共同概念奠定了基础。统一后的数据被用于直接在中央数据库上进行分析,当数据不允许离开本地服务器时,也可通过联合分析进行。这个生态系统有助于回答研究问题,并为科学界提供新的知识。

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