title: Using electronic health records for clinical research: the case of the EHR4CR project.
abstract: OBJECTIVE
  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.
authors.affiliation: 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.
authors.forename: Georges
authors.initials: G
authors.lastname: De Moor
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden.
authors.forename: Mats
authors.initials: M
authors.lastname: Sundgren
authors.affiliation: University College London, London, UK.
authors.forename: Dipak
authors.initials: D
authors.lastname: Kalra
authors.affiliation: Pharma Product Development, F Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Institute of Medical Informatics, University of Münster, Münster, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Dugas
authors.affiliation: Custodix NV, Sint-Martens-Latem, Belgium.
authors.forename: Brecht
authors.initials: B
authors.lastname: Claerhout
authors.affiliation: Coordination Centre for Clinical Trials, Heinrich-Heine-University, Duesseldorf, Germany.
authors.forename: Töresin
authors.initials: T
authors.lastname: Karakoyun
authors.affiliation: Coordination Centre for Clinical Trials, Heinrich-Heine-University, Duesseldorf, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Ohmann
authors.affiliation: Sanofi R&D, Chilly-Mazarin, France.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Lastic
authors.affiliation: Sanofi R&D, Chilly-Mazarin, France.
authors.forename: Nadir
authors.initials: N
authors.lastname: Ammour
authors.affiliation: Clinical Data Interchange Standards Consortium (CDISC), United States.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Kush
authors.affiliation: Data Mining International SA, Geneva, Switzerland.
authors.forename: Danielle
authors.initials: D
authors.lastname: Dupont
authors.affiliation: INSERM CIC-P, CHU de Rennes, Rennes, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Cuggia
authors.affiliation: INSERM, UMR_S 1142, LIMICS, Paris, France; CCS SI Patient, AP-HP, Paris, France.
authors.forename: Christel
authors.initials: C
authors.lastname: Daniel
authors.affiliation: Research in Advanced Medical Informatics and Telematics vzw (RAMIT), Ghent, Belgium.
authors.forename: Geert
authors.initials: G
authors.lastname: Thienpont
authors.affiliation: 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.
authors.forename: Pascal
authors.initials: P
authors.lastname: Coorevits
mesh_terms: D000465:Algorithms; D035843:Biomedical Research / Q000458:organization & administration*; D002318:Cardiovascular Diseases / Q000503:physiopathology; D002986:Clinical Trials as Topic; D003195:Computer Communication Networks; D003199:Computer Systems; D057286:Electronic Health Records; D004867:Equipment Design; D005060:Europe; D006761:Hospitals; D006801:Humans; D016247:Information Storage and Retrieval; D008490:Medical Informatics; D009369:Neoplasms / Q000503:physiopathology; D057188:Workflow
keywords: Clinical research; Clinical trials; Data reuse; Electronic health record; Interoperability; Pharmaceutical industry