August 20, 2013

Electronic health records: new opportunities for clinical research


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Electronic health records: new opportunities for clinical research

  1. Pascal Coorevits1,2,*
  2. Mats Sundgren3,
  3. Gunnar O. Klein4
  4. Anne Bahr5
  5. Brecht Claerhout6
  6. Christel Daniel7
  7. Martin Dugas8
  8. Danielle Dupont9
  9. Andreas Schmidt10
  10. Peter Singleton11
  11. Georges De Moor1,2
  12. Dipak Kalra12
DOI: 10.1111/joim.12119
Cover image for Vol. 274 Issue 3

Journal of Internal Medicine



Keywords:

  • clinical research;
  • electronic health records;
  • research ethics;
  • research techniques

Abstract

Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. While 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 recognised 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 whilst protecting privacy. In the emerging research landscape, co-operation infrastructures are being built where research projects can utilise the availability of patient data from federated EHR systems from many different sites, as well as in international multi-lingual settings. Among 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
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