Electronic Health Records Systems for Clinical Research (EHR4CR)


At a Glance
  • Status: Active Consortium
  • Year Launched: 2011
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • No disease focus
  • Location: Europe
EHR4CR

Abstract

The Innovative Medicines Initiative (IMI) Electronic Health Records Systems for Clinical Research (EHR4CR) project will run over five years (2011-2015) with a budget of more than €16 million and 34 academic and industrial partners. The EHR4CR project is one of the largest public-private partnerships aimed at providing adaptable, reusable, and scalable solutions (tools and services) for reusing data from electronic health records (EHRs) for clinical research. EHR data offer large opportunities for the advancement of medical research, improvement of healthcare, and enhancement of patient safety.

Mission

The EHR4CR project mission is to deliver sustainable, value-added solutions for the trustworthy reuse of eHealth data and information to improve global clinical research. Its vision is to be the trusted gateway to eHealth information for research and knowledge discovery to transform healthcare worldwide. Its values are as follows:

Structure & Governance

A Steering Committee, Executive Committee, Ethics Board, Advisory Board, and Strategic Business Model Innovation forum govern EHR4CR. The Steering Committee consists of all consortium participants and is used for annual project review, approval/removal or participants, and approval of resource shift across Work Packages/project participants. The Executive Committee consists of 11 participants and is used for operational project-leadership, continuous project review, issue resolution, and proposal of changes within projects.

The project involves three Work Packages: Engagement and Business Model, Informatics Tools and Services, and Pilots.

Financing

IMI has contributed €7.2 million, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has contributed €7.7 million in kind, and other sources have contributed €2.1 million, for a total cost of €17.0 million.

Data Sharing

Project deliverables only can be obtained upon request by completing a form on the consortium homepage. Only the deliverables that are accepted by the IMI scientific officers can be requested.

Impact/Accomplishment

EHR4CR produced an animated video in April 2014 detailing the project’s main goal to significantly improve healthcare research by advancing the ability of industry and academia to securely analyze de-identified EHRs, strictly complying with data privacy, ethical, regulatory, and legal policies. The project will enable hospitals to participate more efficiently in more clinical trial programs and, ultimately, will ensure faster access for patients to safe and effective medicines.

Project deliverables only can be obtained upon request by completing a form on the consortium homepage. Only the deliverables that are accepted by the IMI scientific officers can be requested.

Deliverable D1.1: Scenarios, stakeholder requirements, standards, legal and regulatory constraints, gap analysis, medico-economic modeling framework.

Deliverable D2.1: Environment scan (including stakeholders, scenarios, constraints, and opportunities)
Environment scan (including stakeholders, scenarios, constraints and opportunities)
Platform sustainability business model options
Business Model Innovation: value proposition and strategic plan

Deliverable D3.1: Initial EHR4CR architecture and interoperability framework specifications
A snapshot of the architecture description for the EHR4CR platform taken after the first year of the project

Deliverable D4.1: Inventory of information and knowledge models and definition of EHR4CR information models
A major barrier to repurposing routinely collected clinical data for clinical research is that real-world information systems in both domains — patient care and clinical research — use different information models and terminology systems.

Deliverable D5.1: Requirements and specifications of the security and privacy services
Work Package 5 focuses on requirements and specifications of the security and privacy services from legal and technical points of view. This document provides an extended executive summary of the deliverable D5.1.

Deliverable D6.1: Definition of the PFS services (requirements, initial design)
One of the first steps in the design of any clinical study is determining the feasibility of the protocol to be executed.

Deliverable D7.1: Establish specification for data acquisition and standards used, including a concept for local interfaces
This document describes the Work Package 7 deliverable of the first year.

Points of Contact

Project Coordinator
Mats Sundgren
Principal Scientist
Global Clinical Development
AstraZeneca, Sweden
email: mats.sundgren@astrazeneca.com

Deputy Coordinator
Andreas Schmidt, M.Sc., ECPM, Dipl. Pharm. Med. SwAPP, MCPM
Manager European External Collaborations
Clinical Operations and Innovation Management, Product Development
F Hoffmann-La Roche Ltd, Basel Switzerland
email: andreas.schmidt.as3@roche.com

Managing Entity of IMI Beneficiaries:

Dipak Kalra
President of EuroRec
The EuroRec Institute, Belgium
email: dipak.kalra@eurorec.org

Georges De Moor
Past President of EuroRec
The EuroRec Institute, Belgium
email: georges.demoor@eurorec.org

For press inquiries:
email: press@ehr4cr.eu

Sponsors & Partners

AMGEN

Assistance Publique - Hôpitaux de Paris (APHP)

AstraZeneca

Athens University Medical School (UoA)

Bayer Health Care

CDISC Europe Foundation

Custodix NV

eClinical Forum Association

European Association of Health Law Website (EAHL)

European Molecular Biology Laboratory (EMBL-EBI)

European Platform for Patient Organisations (EPPOSI)

F. Hoffmann-La Roche Ltd. (Roche)

Friedrich-Alexander-Universitaet Erlangen-Nürnberg

GlaxoSmithKline

Heinrich-Heine-Universitaet Duesseldorf (representing ECRIN)

Hôpitaux Universitaires de Genève

Institut National de la Santé et de la Recherche Médicale - U872, Eq20

Johnson & Johnson

Kings College London (KCL)

Lilly

Medical University of Warsaw (Polcrin)

MERCK KGaA

RAMIT vzw

Sanofi-Aventis

Telematikplattform für Medizinische Forschungsnetze

The EuroRec Institute (EuroRec) Managing Entity

Université de Rennes (INSERM U936)

University College London (UCL)

University of Dundee

University of Glasgow

University of Manchester

Westfaelische Wilhelms-Universitaet Muenster

Xclinical Gmbh


Last Updated: 04/22/2016

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