Electronic Health Records for Clinical Research

Project Coordinator: Dr. Mats SundgrenGlobal Clinical Development, AstraZeneca, Sweden

Managing entity of IMI beneficiaries:Prof. Dr. Dipak KalraEuroRec President

EHR4CR SHOWCASES ITS PLATFORM AND BUSINESS MODELEHR4CR Annual Conference, Berlin 19-21 November 2013

The EHR4CR project is making great progress with its ambitious targets for the develop-ment and deployment of an innovative technical platform, tools and services for the re-use of electronic health records for clinical research across Europe, together with a business model for sustainability. At a three day event in Berlin, EHR4CR brought together the consortium Steering Committee, Business Modelling Innovation Strategic Forum and key service industry stakeholders for its first Stakeholder Awareness session.

Steering CommitteeThe main achievements of the project during 2103 project were presented to consortium partners and invited guests. Substantial progress has been made within all of the EHR4CR scenarios, namely: 1) protocol feasibility assessment 2) patient identification and recruit-ment 3) clinical study conduct, and, 4) serious adverse event reporting. Key opinion leader interviews have been conducted across the consortium countries, indicating a very positive attitude to the re-use of EHRs for research, and an endorsement of the specific scenarios. The proposals for sustainability have consolidated around a not-for-profit EHR4CR Institute and one or more for-profit Service Providers, for which a successful five year business model has been established. In addition, a robust cost-bene-fit assessment has been modelled from the perspective of the pharmaceutical industry to assess and compare the value of EHR4CR versus current practices.The requirements and specifications for Scenario 3, Clinical Study Conduct, have success-fully passed the Stage Gate for handover to the technical Work Package Group for imple-mentation. The requirements and implementation plan for Scenario 4, Serious Adverse Event reporting, have been incorporated within Scenario 3. Plans for evaluation of the Protocol Feasibility Pilot have been developed in collaboration with the Pilots work package.The platform and services for Protocol Feasibility have been enhanced based on feedback from first user testing and the needs of Scenario 2 (Patient Recruitment). There is now a clear plan for the handover of the Protocol Feasibility prototype to the Pilots work package for formalised testing. Development work on Patient Recruitment has occurred in parallel and is well advanced.Protocol Feasibility data modelling has identified a recurring subset of key data elements that can be mapped against data availability within each pilot site. This greatly simplifies the formal testing of the Protocol Feasibility platform. The volume and quality of data across sites may make the business case difficult today for Scenario 3 (high effort to set up, few sites, and low data volumes) and the Pilots work package will undertake a thorough review to quantify the gap.

Annual Conference

Berlin

18 - 19 -20November 2013

SUPPORTED BY

The EHR4CR project is partially funded by the IMI Programme.

The Innovative Medicines Initia-tive (IMI) is a unique public-pri-vate partnership designed by the European Commission and Euro-pean Federation of Pharmaceuti-cal Industries and Associations (EFPIA). It is a pan-European collaboration that brings togeth-er large biopharmaceutical com-panies, small- and medium-sized enterprises (SMEs), patient organisations, academia, hospi-tals and public authorities

¹An Overview of the Stakeholder Awareness session is available as a separate document: “The EHR4CR Project Showcases Achievements”

Electronic Health Records for Clinical Research

Business Model Innovation Strategic ForumSince project initiation in 2011, the EHR4CR project has conducted yearly consultative meetings with a group of senior managers, primarily from EFPIA participating partners, to comment on the development of the EHR4CR business model, including evidence-based value propositions. This year, the technological functionalities of the EHR4CR platform were showcased in the frame of a commented video simulation. In addition, using the perspective of the pharmaceutical industry, the methodology and preliminary results of the EHR4CR cost-benefit assessment were introduced aiming to establish the value of EHR4CR services compared to current pratices. The EHR4CR business model framework and simulations were also presented from the perspective of the EHR4CR service provid-ers. Using best practices, state-of-the-art methodologies, advanced modeling, and sensi-tivity analyses, these assessments have been conducted within a multidisciplinary business model innovation task force (BMI-TF) of EHR4CR partners. These evaluations will be submitted for publication and dissemination as an integral part of the EHR4CR commu-nication strategy during 2014.

Stakeholder Awareness Session¹Although it will only complete in 2015, the meeting in Berlin provided an opportunity for consortium members to brief key stakeholder groups from the service industries and to exchange ideas on potential areas for synergy and co-operation, as the project starts to prepare for commercialisation.A presentation delivered by Mats Sungren, Richard Perkins, Dipak Kalra and Danielle Dupont, introduced participants to the background to the project, its vision for the future, key challenges, achievements to date and next steps. A series of interactive booths allowed invited stakeholders to consolidate and extend their understanding through demonstrations of the results of each Work Package.During a Question and Answer session, led by Andreas Schmidt, the group highlighted the new opportunities for service providers and data providers being created by EHR4CR and reinforced that engagement from stakeholders is key to the future success and sustainabil-ity of EHR4CR services. Concerns were expressed about the volume and quality of today’s EHR data and the need for incentives and future innovation to drive enrichment.Feedback from this first Stakeholder Awareness session in Berlin was highly positive and will be followed with further events as the project engages with a growing number of stakeholder groups. The second in the planned series of Stakeholder Awareness Confer-ences will take place in Brussels on April, 9 2014 and will primarily focus on engagement with hospitals and data providers.

www.ehr4cr.eu