Rob Thwaites , EFPIA EHR task force

1. Toward integration of clinical care and clinical research for better health and high quality healthcareRecommendations from Interaction Stream at October Workshop Rob Thwaites, EFPIA EHR task force EHR stakeholder workshop – 10-11th March 2008

2. The Interaction Stream highlighted organisational challenges to capturing the potential of EHRs for clinical research and suggested approaches for the way forward • There are many potential uses for EHRs in future clinical research • While the other two Streams identified technical and legal challenges, the Interaction Stream focused on three organisational challenges to be addressed: • Provision and use of data for both research and care • The potential models for third parties and the services provided • Where the costs and benefits to greater integration might fall • The Interaction workstream recommended four areas of focus for future work at a European level • Definition of services • Communication of uses of EHR for clinical research • Role of third party (parties) • Means for ongoing collaboration EHR stakeholder workshop – 10-11th March 2008 2

3. There are many potential uses for EHRs in future clinical research 15 use cases identified in the “Slipstream” project Regulatory/ Safety Research Development Commercial Genetic association and linkage analysis Clinical validation – target, biomarker and diagnostic Clinical trial simulation Clinical trial execution Identification of new indications Interim analyses Post-marketing use and safety Manufacturing recall Pharmacoeconomics Comparative marketing studies Pharmaceutical/ Disease management programmes E-prescribing Personalized medicine - pharmacogenomics Outcomes studies Disease and care management modelling EHR stakeholder workshop – 10-11th March 2008 3

4. While the other two Streams identified technical and legal challenges, the Interaction Stream focused on three organisational challenges to be addressed • Provision and use of data for both research and care • How can we improve the quality and completeness of data? • How can we share clinical research data? • Under what circumstances should data be available to commercial enterprises? • The potential models for third parties and the services provided • What models already exist and what benefits do they provide • What are the requirements for third parties? • Where the costs and benefits to greater integration might fall • Benefits to investing in EHRs, and EHR integration, will not necessarily accrue to the ones who finance this • What could be the role of governments/EU in overcoming this market failure? • Will recovering the costs involve significant changes to the way we work? EHR stakeholder workshop – 10-11th March 2008 4

5. The Interaction workstream recommended four areas of focus for future work at a European level • Define the services that would characterise or facilitate greater integration • Define pilot building upon CRFQ • Better communicate the uses of EHR and benefits for clinical research • (still need to draft a communication plan) • Explore the usefulness of third parties • Catalogue existing third parties/ define future roles (with other Streams) • Clarify how HC providers/pharma/vendors collaboration could continue • Build on existing forum/methods…EC/EUROREC/EFPIA EHR stakeholder workshop – 10-11th March 2008 5