EHR stakeholder workshop – 10-11th March 2008 1

Toward integration of clinical care and clinical Toward integration of clinical care and clinical research for better health and high quality research for better health and high quality

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Recommendations from Interaction Stream at Recommendations from Interaction Stream at October WorkshopOctober Workshop

Rob ThwaitesRob 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 3

There are many potential uses for EHRs in future clinical research

15 use cases identified in the “Slipstream” project

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

Research Regulatory/ Safety

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 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 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