Current medical needs, the growth of targeted therapies and personalized medicines and escalating R&D costs result in formidable cost pressures on healthcare systems and the pharmaceutical industry.Clinical research is also growing in complexity, labour intensity and cost. There is a growing realization that the development and integration of Electronic Health Record systems (EHRs) for medical research can:
- enable substantial efficiency gains
- make Europe more attractive for R&D investment
- provide patients better access to innovative medicines and improved health outcomes.
EHRs can now be designed to seamlessly integrate with existing research platforms and healthcare networks to create opportunities for many stakeholders, including the pharmaceutical and bio-pharma industries.
However, key challenges are compliance with various ethical, legal and privacy requirements (and acceptance by the general public, patients, and medical professionals), providing a platform that works across many EHR systems and is sustainable within a scalable business model. A 4-year project, EHR4CR will involve a team of recognised European academic and industrial partners.
The project will build a platform to enable the use of EHR for more efficient medical research and run pilots (on interoperability, security, data quality, data storage solutions, organisational issues,accreditation and certification, etc) to demonstrate the viability and scalability of an EHR4CR business model.
The EHR4CR project supports the IMI strategic agenda with an information gateway solution to enhance clinical research efficiency and innovation. A key IMI aspect is the development of a knowledge management capability that can, for example, provide information management support for other research on personalized medicines, now an IMI 2010 call topic. EHR4CR also supports other IMI R&D projects by enabling the use (and reuse) of large amounts of health data – in an ethical and cost-effective way.
The EHR4CR project consortium draws its expert partners from academia, with 20 organisations and 4 SMEs working with 10 EFPIA companies and is an example of the scale of collaboration made possible through IMI.
Achievements & News
Stakeholders in favour of using electronic health records for clinical research, EHR4CR project survey shows
An overwhelming majority (95%) of stakeholders are in favour of using electronic health records (EHR) in clinical research, according to the results of a recent survey run by IMI project EHR4CR (‘Electronic health records for clinical research’).###The goal of the project is to come up with a platform and business model to enable the re-use of data from EHRs for clinical research in Europe. The EHR4CR team set up the survey to identify opportunities and challenges in this area. The survey gathered around 200 responses from researchers in academia, the pharmaceutical industry, EHR system providers, patients’ organisations and others. Most highlighted complying with legislative, regulatory, ethical and privacy requirements as a top priority for the successful use of EHR services for clinical research. ‘The results of this survey confirm a high interest in re-using EHR data for clinical research with the objective to optimise drug development efficiency and access to innovative medicines in Europe,’ the project team states. ‘This survey provides valuable information towards achieving the development and implementation of EHR4CR services and of a sustainable and scalable business model.’ The team’s findings will be published in a forthcoming issue of iHealth Connections.
- Amgen NV, Belgium
- AstraZeneca AB, Sweden
- Bayer Schering Pharma AG, Germany
- Eli Lilly, UK
- F. Hoffmann-La Roche Ltd, Switzerland
- GlaxoSmithKline Research & Development, UK
- Janssen Pharmaceutica NV, Belgium
- Merck KGaA, Germany
- Novartis Pharma AG, Switzerland
- Sanofi-Aventis Research and Development, France
UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT
- eClinical Forum Association, France
- European Association of Health Law, University of Edinburgh, UK
- European Institute for Health Records, France
- European Molecular Biology Laboratory, Germany
- European Platform for Patients‘ Oganisations, Science and Industry, Belgium
- Friedrich-Alexander University, Erlangen-Nürnberg, Germany
- Heinrich-Heine University, Düsseldorf (representing ECRIN), Germany
- King‘s College London, UK
- Medical University of Warsaw, Poland
- National and Kapodistrian University of Athens, Greece
- National Institute for Health & Medical Research (INSERM), France
- Public Service – Hospitals of Paris, France
- Telematics Platform Medical Research Networks, Germany
- University College London, UK
- University Hospital of Geneva, Switzerland
- University of Dundee, UK
- University of Edinburgh, UK
- University of Glasgow, UK
- University of Manchester, UK
- University of Rennes 1, France
- Westfälische Wilhelms University, Münster, Germany
- Assero Limited (representing CDISC), UK
- Custodix NV, Belgium
- Data Mining International, Switzerland (sub-contracting partner)
- XClinical GmbH, Germany
Facts & Figures
|IMI funding||7 019 046|
|EFPIA in-kind||7 042 616|
|Other||1 989 852|
|Total Cost||16 051 514|
Global Clinical Development
Managing entity of IMI beneficiaries
Prof. Dr. Georges de Moor
The EuroRec Institute
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