Georges De Moor1, Mats Sundgren2, Dipak Kalra3, Andreas Schmidt4, Martin Dugas5, Brecht Claerhout6, Töresin Karakoyun7, Christian Ohmann7, Pierre-Yves Lastic8, Nadir Ammour8, Rebecca Kush9, Danielle Dupont10, Marc Cuggia11, Christel Daniel12, Geert Thienpont13, Pascal Coorevits14. 1. Department of Public Health, Unit of Medical Informatics and Statistics, Ghent University, Ghent, Belgium; The European Institute for Health Records (EuroRec), Sint-Martens-Latem, Belgium; Custodix NV, Sint-Martens-Latem, Belgium. 2. AstraZeneca R&D, Mölndal, Sweden. 3. University College London, London, UK. 4. Pharma Product Development, F Hoffmann-La Roche Ltd, Basel, Switzerland. 5. Institute of Medical Informatics, University of Münster, Münster, Germany. 6. Custodix NV, Sint-Martens-Latem, Belgium. 7. Coordination Centre for Clinical Trials, Heinrich-Heine-University, Duesseldorf, Germany. 8. Sanofi R&D, Chilly-Mazarin, France. 9. Clinical Data Interchange Standards Consortium (CDISC), United States. 10. Data Mining International SA, Geneva, Switzerland. 11. INSERM CIC-P, CHU de Rennes, Rennes, France. 12. INSERM, UMR_S 1142, LIMICS, Paris, France; CCS SI Patient, AP-HP, Paris, France. 13. Research in Advanced Medical Informatics and Telematics vzw (RAMIT), Ghent, Belgium. 14. Department of Public Health, Unit of Medical Informatics and Statistics, Ghent University, Ghent, Belgium; The European Institute for Health Records (EuroRec), Sint-Martens-Latem, Belgium. Electronic address: pascal.coorevits@telenet.be.
Abstract
OBJECTIVES: To describe the IMI EHR4CR project which is designing and developing, and aims to demonstrate, a scalable, widely acceptable and efficient approach to interoperability between EHR systems and clinical research systems. METHODS: The IMI EHR4CR project is combining and extending several previously isolated state-of-the-art technical components through a new approach to develop a platform for reusing EHR data to support medical research. This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, patient identification and recruitment, clinical trial execution and serious adverse event reporting), with various local and national stakeholders across several countries and therefore under various legal frameworks. RESULTS: An initial instance of the platform has been built, providing communication, security and terminology services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. Proof-of-concept demonstrators have been built and evaluated for the protocol feasibility and patient recruitment scenarios. The specifications of the clinical trial execution and the adverse event reporting scenarios have been documented and reviewed. CONCLUSIONS: Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies.
OBJECTIVES: To describe the IMI EHR4CR project which is designing and developing, and aims to demonstrate, a scalable, widely acceptable and efficient approach to interoperability between EHR systems and clinical research systems. METHODS: The IMI EHR4CR project is combining and extending several previously isolated state-of-the-art technical components through a new approach to develop a platform for reusing EHR data to support medical research. This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, patient identification and recruitment, clinical trial execution and serious adverse event reporting), with various local and national stakeholders across several countries and therefore under various legal frameworks. RESULTS: An initial instance of the platform has been built, providing communication, security and terminology services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. Proof-of-concept demonstrators have been built and evaluated for the protocol feasibility and patient recruitment scenarios. The specifications of the clinical trial execution and the adverse event reporting scenarios have been documented and reviewed. CONCLUSIONS: Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies.
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