• The IMI EHR4CR project runs over 4 years (2011-2014) with a budget of +16 million € and involves 33 partners (academic and industrial)
• The EHRCR project is -to date- one of the largest public-private partnerships aiming at providing adaptable, reusable and scalable solutions (tools and services) for reusing data from Electronic Health Record systems for Clinical Research.
• Electronic Health Record (EHR) data offer large opportunities for the advancement of medical research, the improvement of healthcare, and the enhancement of patient safety.

The expected outputs of the project are:

• Requirements specification
• The EHR4CR Business Model
• The EHR4CR Technical Platform (a set of tools and services)
• Pilots for validating the solutions:
  • for different scenarios (e.g. protocol feasibility, patient recruitment,...);
  • across different therapeutic areas (e.g. oncology);
  • across several countries (under different legal frameworks).

• Clinical protocol feasibility
• Patient identification and recruitment
• Clinical trial execution
• Adverse event reporting

• Provisional list:
• Oncology
• Inflammatory diseases
• Neuroscience
• Diabetes
• Cardiovascular diseases
• Respiratory diseases

The 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.

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.

Accreditation of Clinical Research Units and Certification of EHR systems will accelerate the adoption of a more harmonised approach throughout Europe and serve as a powerful means for ensuring to the pharmaceutical industry the reliability and trustworthiness of the research partners (i.e. of the data providers, e.g. hospitals).

The EHR4CR approach will thus also 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.

The EHR4CR business model for re-using EHR data in research aims at offering benefits for all stakeholders and strengthen the collaboration amongst all the partners in research.

Academic perspective:

• Provide tools and services to better plan and conduct academic trials (investigator-initiated trials)
• Facilitate comparative effectiveness research

Pharmaceutical perspective:

• Improve speed and quality of the 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

General Healthcare perspective:

• Significant facilitation of the re-use of EHR data to allow more efficient management of public health issues
• Closer co-ordination between care providers and patients, resulting in safer and more evidence-based diagnosis and treatment

EHR4CR represents a paradigm shift given the holistic and multi-disciplinary approach in the development of its Business Model with:

• Benefits for the participating EFPIA companies and the entire pharmaceutical industry
• Benefits for the IMI program (cf. the IMI JU key objectives)
• Benefits for the hospital data providers, the EHR system vendors, the clinical researchers…
• Benefits for the patients

Agreed starting point for the Protocol Feasibility Scenario: