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Electronic health records: new opportunities for clinical research
Ghent University, Ghent, Belgium; The European Institute for Health Records (EuroRec), Sint-Martens-Latem, Belgium.
AstraZeneca R&D, Mölndal, Sweden.
University of Science and Technology, Trondheim, Norway. (eHälsa)ORCID iD: 0000-0002-1337-2394
Sanofi R&D, Chilly-Mazarin, France.
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2013 (English)In: Journal of Internal Medicine, ISSN 0954-6820, E-ISSN 1365-2796, Vol. 274, no 6, 547-60 p.Article in journal (Refereed) Published
Abstract [en]

Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources.

Place, publisher, year, edition, pages
Wiley-Blackwell, 2013. Vol. 274, no 6, 547-60 p.
National Category
Other Health Sciences
Research subject
URN: urn:nbn:se:oru:diva-41749DOI: 10.1111/joim.12119ISI: 000330102100006PubMedID: 23952476ScopusID: 2-s2.0-84887401594OAI: diva2:791833
Available from: 2015-03-02 Created: 2015-01-15 Last updated: 2015-08-06Bibliographically approved

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