Using electronic health records for clinical research: The case of the EHR4CR project

Abstract

Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies.

Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe

“…(http://www.ehr4cr.eu/) was to develop a scalable pan-European platform during a 5-year European research project (2011)(2012)(2013)(2014)(2015) funded by the European Commission and by the European Federation of Pharmaceutical Industries and Associations (EFPIA), in the frame of the Innovative Medicines Initiative Joint Undertaking Programme (IMI-JU) [21].…”

“…With a budget of over 16 million Euros, the EHR4CR consortium involved 34 academic and private partners (10 pharmaceutical companies), and included 11 hospital sites in France, Germany, Poland, Switzerland and the United Kingdom. It is to date one of the largest of the IMI public-private partnership in this area [21].…”

“…Importantly, the EHR4CR platform has been specially designed and engineered to unlock the contribution of health data from hospital EHR systems, in compliance with the ethical, regulatory and data protection policies and requirements of each participating country, to enable three clinical research scenarios (S): Scenario 1 (S1): Improving protocol feasibility assessments, Scenario 2 (S2): Enhancing and speeding up patient identification for recruitment in clinical trials, and Scenario 3 (S3): Optimising clinical trial data exchange, including for the reporting of severe adverse events (SAE) [21].…”

“…Detailed descriptions of the EHR4CR platform and services have been published [21,22]. The EHR4CR platform supports distributed querying to enhance and speed up clinical trial feasibility assessments, patient identification for recruitment, and clinical study execution.…”

“…In particular, as the pilot sites were active in clinical research, they were able to provide exemplary local governance requirements to complement the ethical inputs referred to above. To enable wide adoption by EHR vendors, and quality assurance of the EHR4CR platform within hospitals, the project developed robust governance through accreditation and certification programmes for establishing best practices [21].…”