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    PowerPoint Presentation PowerPoint Presentation Presentation Transcript

    • Overview of the EHR4CR projectElectronic Health Record Systems for Clinical Research
      October 1, 2010
      http://www.ehr4cr.eu
    • 2
      The purpose of this presentation
      This material is intended for external stakeholders, forums and conferences through the responsibility of the primary contact person within the EHR4CR consortium (Mats.Sundgren@astrazeneca.com).
      October 1, 2010
      EHR4CR Executive Committee
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 3
      Executive Summary
      EHR4CR will move beyond the current state-of-the-art by combining previously isolated informatics progress (e.g. semantic interoperability, privacy enhancing techniques, and standards) with an entirely new approach to reusing EHR data for supporting medical research, underpinned by a comprehensive business model for governance, acceptance, adoption and sustainability.
      The project will demonstrate the viability and scalability of the EHR4CR business model through pilots (e.g. platform services designed for protocol feasibility, patient recruitment, and clinical trial data capture).
      The IMI EHR4CR project will run over 4 years with a budget of €13 million and involve 33 recognised European academic and industrial partners.
      The EHRCR will be the largest public-private partnership to date with the goal to tie interoperability aspects together to provide adaptable, reusable and scalable solutions and be the first step to a pan-EU capability for clinical research with integrated interoperability for clinics across countries in Europe.
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 4
      Problem statement for T9(2nd call 2009 / Topic 9)
      A sustainable business model for using EHR data for research purposes in Europe is required
      to realise the potential of enhanced research, development, and safety through the expanded use of health information technology
      There is a gap between:
      technology solutions,
      regional diversity, individual approaches and
      the lack of a common viable business model across Europe
      Overall, EHR data offers large opportunities for the advancement of medical research, the improvement of healthcare, and the enhancement of patient safety.
      Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010
    • 5
      Project objective & outputs
      The EHR4CR project will move beyond the current state-of-the-art by means of combining previously isolated informatics progress with an entirely new approach to develop a platform and business model for re-using EHR data for supporting medical research.
      The outputs of the project are:
      • Specification of the Requirements and a Business Model
      • Technical Platform (a set of tools and services)
      • Different Pilots for validating the solutions:
      • for different scenarios (e.g. patient recruitment);
      • across different therapeutic areas (e.g. oncology);
      • across several countries (under different legal frameworks).
      Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010
    • 6
      Benefits
      Accreditation and certification will enable research and clinical trials to be delivered more cost effectively. Both vendors of certified products and hospitals (source data) that will be accredited will have a competitive advantage.
      A new business model for re-using EHR data in research will aim at offering benefits for “all” stakeholders and strengthen the collaboration amongst “all” the partners in Research... !
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 7
      Socio-economic impact
      The EHR4CR project represents a paradigm shift given the holistic and multi-disciplinary approach in the development of a robust business model
      Benefits to the participating EFPIA companies and the entire pharmaceutical industry
      Benefits to the IMI program and in relation to the IMI JU key objectives
      Benefits to patients, health care, academic research and innovation.
      Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010
    • 8
      Examples of benefits
      Patients and health care perspective:
      Closer co-ordination between care providers and patients, resulting in safer and more evidence-based diagnosis and treatment
      Significantly facilitate re-use of EHR data to allow more efficient management of public health issues
      Academic perspective
      Provide tools and services to better plan and conduct academic trials (investigator-initiated trials)
      Facilitate comparative effectiveness research, e.g. paediatric trials, trials on rare diseases, trials with biotherapy)
      Pharmaceutical perspective:
      Improve speed and quality of clinical patient recruitment process and study design by accurate understanding of real patient populations
      Support to conduct observational and outcomes research studies in real-world settings
      Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010
    • 9
      EHR4CR Business model
      EHR4CR business model will:
      Specify in detail the product and service offering;
      Include analyses and an impact analysis on multiple stakeholders;
      Deliver a self-sustaining economic model including sensitivity analysis;
      Define appropriate governance arrangements for the platform services and for pan-European EHR4CR networks;
      Define operating procedures and trusted third party service requirements;
      Identify the value proposition and incentives for each of the key players and stakeholders impacted by EHR4CR;
      Define accreditation and certification plans for EHR systems capable of interfacing with the platform;
      Provide a framework to define public and private sector roles in reusing EHRs for clinical research;
      Define a roadmap for pan-European adoption and for funding future developments.
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 10
      EHR4CR Technical Platform
      EHR4CR platform will:
      Support the feasibility, exploration, design and execution of clinical studies and long-term surveillance of patient populations;
      Enable trial eligibility and recruitment criteria to be expressed in ways that permit searching for relevant patients across distributed EHR systems, and initiate confidentially participation requests via the patients’ authorised clinicians;
      Provide harmonised access to multiple heterogeneous and distributed clinical (EHR) systems and integration with existing clinical trials infrastructure products (e.g. EDC systems);
      Facilitate improvements of data quality to enable routine clinical data to contribute to clinical trials, and importantly vice versa, thereby reducing redundant data capture.
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 11
      Project plan overview
      Consensus Panel Meeting, 16 July 2010 - 2nd stage of IMI JU Evaluation 2nd call 2009 / T9 - EHR
    • 12
      Status in 2010
      Stage 1 (Consortia evaluation & selection) - completed in March
      • Forming one EHR4CR consortia of 32 private and public partners to develop a full project proposal for 2009 IMI call topic 9
      • The project is coordinated by AZ
      • EuroRec acts as managing entity for public partners
      • Roche acts as deputy coordinator and E Lilly to cover Project Management
      Stage 2 (Full project proposal) – completed July
      • June 28th: Full Project Proposal submitted
      • July 16th: IMI Consensus Expert Panel Meeting
      • July 20th: IMI Governing board decision on the list of full project proposals
      • August 5th: IMI preliminary feedback that the full project plan ranked high score and is going to pass the 2nd stage of IMI JU Evaluation
      • September 19th: Novartis will join the EHR4CR project
      • Preparations is now underway to finalise the final grant and project agreement during Q3.
      Stage 3 – planned project start
      • Between Q4 2010 and Q1 2011.
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 13
      The partners
      10* Pharmaceutical Companies (members of EFPIA)
      22 Public Partners (Academia, Hospitals and SMEs)
      5 Subcontractors (Advisory Board).
      * May increase up to 11 pharmaceutical companies
      Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010
    • 14
      Governance structure
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 15
      The partners
      Communication on the IMI 2nd call 2009 EHR4CR Project - October 1, 2010
    • 16
      Bridging the gap
      In Price Waterhouse Cooper report on “Transforming Healthcare through Secondary Use of Health Data” (October, 2009) one of the key messages is:
      What it means for your business?
      “Industry stakeholders are calling for a framework to define public and private sector roles in secondary data use”
      This is exactly what EHR4CR is all about
      Communication on the IMI 2nd call 2009 EHR4CR Project – October 1, 2010