EHR4CR

Electronic Health Records Systems for Clinical Research
Electronic Health Records 4 Clinical Research

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 2
Grant agreement number
115189

Contributions
IMI Funding
7 194 044
EFPIA in kind
7 555 883
Other
1 954 482
Total Cost16 704 409

Summary

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

Save the date! Health data event on 10 March 2016
The inaugural conference of the European Institute for Innovation through Health Data (i~HD) will be held in Paris, France on 10 March 2016. i~HD is a non-profit institute that was born out of the IMI electronic health records project EHR4CR and other related projects. ### Its mission is to guide and catalyse the quality, interoperability and trustworthy uses of health data, for optimising health and knowledge discovery. This inaugural conference will mark the launch of a novel European platform to support multi-centre clinical research. This operational platform, the result of EHR4CR, can connect securely to the data within multiple hospital electronic health record (HER) systems and clinical data warehouses across Europe, to enable a trial sponsor to predict the number of eligible patients for a candidate clinical trial protocol, to assess its feasibility and to locate the most relevant hospital sites. Also on the agenda is IMI’s EMIF project, Europe’s largest ‘big data’ project in health. The conference will also spotlight the challenges and state-of-the-art approaches to improving the quality and interoperability of clinical data. i~HD will play an important future role in the development and quality labelling of interoperability standards, bringing together clinical and research domain experts, with patients, to help ensure that future standards support patient care, learning health systems and clinical research. The event is invitation only; those who wish to attend should express their interest via this form

New EHR4CR video
IMI’s EHR4CR project has produced a new animated video detailing the project’s main goal: to significantly improve healthcare research by advancing the ability of industry and academia to securely analyse ###de-identifed electronic health records, strictly  complying with data privacy, ethical, regulatory and legal policies. The project will also enable hospitals to participate more efficiently in more clinical trial programmes and, ultimately, ensure faster access for patients to safe and effective medicines.
(April 2014)

EHR4CR video
IMI’s EHR4CR project has produced a video explaining how the project works. The goal of EHR4CR is to build, validate and deploy a Europe-wide innovative technological platform ###to re-use data from electronic health records (EHRs) for clinical research purposes while ensuring compliance with all applicable legislative, regulatory, ethical and privacy protection requirements and policies. The video can be downloaded from the homepage of the EHR4CR website.
(March 2013)


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.
(November 2011)

Participants Show participants on map

EFPIA companies
  • Amgen NV, Brussels, Belgium
  • AstraZeneca AB, Södertälje, Sweden
  • Bayer AG, Berlin, Germany
  • Eli Lilly and Company Ltd, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Glaxosmithkline Research And Development LTD, Brentford, Middlesex, United Kingdom
  • Janssen Pharmaceutica NV, Beerse, Belgium
  • Merck KGaA, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Sanofi-Aventis Research and Development, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
  • CDISC Europe Foundation, Brussels, Belgium
  • European Institute For Health Records , Lille, France
  • European Molecular Biology Laboratory, Heidelberg, Germany
  • European Platform for Patients Oganisations, Science and Industry, Leuven, Belgium
  • Friedrich-Alexander University (FAU) Erlangen-Nürnberg, Erlangen, Germany
  • Heinrich-Heine-Universitaet Duesseldorf, Düsseldorf, Germany
  • Hôpital de la Salpêtrière, Paris , France
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
  • King's College London, London, United Kingdom
  • Medical University of Warsaw, Warsaw, Poland
  • National & Kapodistrian University of Athens, Athens, Greece
  • RESEARCH IN ADVANCED MEDICAL INFORMATION AND TELEMATICS vzw, Zwalm, Belgium
  • Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V., Berlin, Germany
  • The University of Manchester, Manchester, United Kingdom
  • University College London, London, United Kingdom
  • University of Dundee, Dundee, United Kingdom
  • University of Edinburgh, Edinburgh, United Kingdom
  • University of Glasgow, Glasgow, United Kingdom
  • Université de Rennes 1, Rennes, France
  • Westfaelische Wilhelms-Universitaet Muenster, Münster, Germany
  • eClinical Forum Association, Friesenheim, France
Small and medium-sized enterprises (SMEs)
  • Custodix NV, Sint-Martens-Latem, Belgium
  • XClinical GmbH, Munich, Germany
Patient organisations
  • Les hôpitaux universitaires de Genève, Geneva, Switzerland
Third parties
  • Consept Consulting SARL, Friesenheim, France
  • Neptunus Data Aktiebolag, Saltsjöbaden, Sweden

CONTACT

Project coordinator
Mats Sundgren
Global Clinical Development, AstraZeneca
Sweden
mats.sundgren[at]astrazeneca.com
Managing entity
Dipak Kalra
EUROPEAN INSTITUTE FOR HEALTH RECORDS
d.kalra[at]ucl.ac.uk
Managing entity
Prof. Dr. Georges De Moor
European Institute for Health Records
Belgium
georges.demoor[at]eurorec.org
For press inquiries
press[at]ehr4cr.eu