<br>电子健康记录（EHR）在临床研究和平台试验中的应用：EU-PEARL 开发的基于 EHR 的创新方法的应用,Journal of Biomedical informatics

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电子健康记录（EHR）在临床研究和平台试验中的应用：EU-PEARL 开发的基于 EHR 的创新方法的应用
Journal of Biomedical informatics ( IF 4.0 ) Pub Date : 2023-11-22 , DOI: 10.1016/j.jbi.2023.104553
Giulia Lombardo ₁ , Camille Couvert ₂ , Melisa Kose ₁ , Amina Begum ₁ , Cecile Spiertz ₃ , Courtney Worrell ₁ , Danny Hasselbaink ₄ , Eva-Maria Didden ₅ , Luca Sforzini ₁ , Marija Todorovic ₆ , Martine Lewi ₇ , Mollie Brown ₁ , Morgan Vaterkowski ₈ , Nancy Gullet ₁ , Nare Amasi-Hartoonian ₁ , Nicolas Griffon ₉ , Raluca Pais ₁₀ , Sarai Rodriguez Navarro ₁₁ , Andreas Kremer ₁₂ , Christophe Maes ₁₃ , Eng Hooi Tan ₁₄ , Maxim Moinat ₁₅ , Joan Genescà Ferrer ₁₁ , Carmine M Pariante ₁ , Dipak Kalra ₁₆ , Nadir Ammour ₂ , Susana Kalko ₁₁

Affiliation

King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
Sanofi R&D, Global Development, Clinical Science & Operations, Chilly-Mazarin, France.
The Janssen Pharmaceutical Companies of Johnson & Johnson, Leiden, The Netherlands.
Janssen Biologics B.V., Leiden, the Netherlands.
Actelion, a Janssen company of Johnson & Johnson, Allschwil, Basel-Country, Switzerland.
Johnson & Johnson Clinical Operations (JJCO), Johnson & Johnson company, Belgrade, Serbia.
Global Commercial Strategy Organization, the Janssen Pharmaceutical Companies of Johnson & Johnson, Raritan, New Jersey, USA.
Assistance Publique Hôpitaux de Paris, IT Department, Innovation and Data, Paris, France, and EPITA EPITA School of Engineering and Computer Science, Paris, France.
Information Technology Department, AP-HP, Paris, France; LIMICS, Inserm U1142, Sorbonne Université, Paris, France.
Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Institute of Cardiometabolism and Nutrition, INSERM UMRS_938, Paris, France.
Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.
Information Technology for Translational Medicine, ITTM S.A, House of BioHealth, Esch-sur-Alzette, Luxembourg.
The European Institute for Innovation through health data, and Department Public Health and Primary Care, Unit of Medical Informatics and Statistics, Faculty of Medicine and Health Sciences, Ghent University, Gent, Belgium.
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Erasmus University Medical Center, Rotterdam, the Netherlands.
The European Institute for Innovation through Health Data and Visiting Professor, University of Ghent, Gent, Belgium.

电子健康记录（EHR）系统是临床实践中的数字平台，用于收集患者与其健康状况相关的临床信息，并代表了真实世界数据的有用存储。EHR 在研究中具有潜在作用，尤其是在平台试验中。平台试验是创新的试验设计，包括在单个主方案下对不同治疗进行多个试验组（同时和/或序贯进行）。然而，在研究中使用 EHR 会带来重要的挑战，例如记录不完整以及需要将试验资格标准转化为可互操作的查询。在本文中，我们旨在回顾和描述我们提出的创新方法，以应对已确定的一些最重要的挑战。这项工作是创新药物倡议（IMI）欧盟 Patient-cEntric clinicAl tRial pLatforms （EU-PEARL）项目工作包 3 （WP3）的一部分，其目标是为基于 EHR 的方案可行性评估、临床地点选择和平台试验中的患者预筛选提供工具和指导，投资于构建数据驱动的临床网络框架，该框架可以执行这些复杂的创新设计，其中可行性评估至关重要。

"点击查看英文标题和摘要"

Electronic health records (EHRs) in clinical research and platform trials: Application of the innovative EHR-based methods developed by EU-PEARL

Electronic Health Record (EHR) systems are digital platforms in clinical practice used to collect patients’ clinical information related to their health status and represents a useful storage of real-world data. EHRs have a potential role in research studies, in particular, in platform trials. Platform trials are innovative trial designs including multiple trial arms (conducted simultaneously and/or sequentially) on different treatments under a single master protocol. However, the use of EHRs in research comes with important challenges such as incompleteness of records and the need to translate trial eligibility criteria into interoperable queries. In this paper, we aim to review and to describe our proposed innovative methods to tackle some of the most important challenges identified. This work is part of the Innovative Medicines Initiative (IMI) EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project’s work package 3 (WP3), whose objective is to deliver tools and guidance for EHR-based protocol feasibility assessment, clinical site selection, and patient pre-screening in platform trials, investing in the building of a data-driven clinical network framework that can execute these complex innovative designs for which feasibility assessments are critically important.

更新日期：2023-11-22

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