EHR integration for clinical research: toward new interaction models ?

1. EHR integration for clinical research: toward new interaction models ? Isabelle de Zegher EHR stakeholder workshop – 11th October 2007

2. Hospital Hospital Hospital Hospital GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office Pharma Industry Pharma Industry Pharma Industry Clinical Care and Clinical Research2 separate “electronic” worlds…. EDC(electronic data capture) EHR stakeholder workshop – 11th October 2007 2

3. Patient recruitment Clinical trial simulation New indication identification Hospital Hospital Hospital Hospital GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office GP’s Office Personalized medicine Pharmacovigilance Pharmaco-economics ePrescribing Predictive safety Pharma Industry Pharma Industry Pharma Industry Pharmaceutical/disease management Clinical Care and Clinical Research..who will benefit from electronic data exchange EDC(electronic data capture) EHR stakeholder workshop – 11th October 2007 3

4. Potential use cases for EHR EHR stakeholder workshop – 11th October 2007 4 Source: Splitstream project

5. “Organizational” aspects of EHR integration • Technology is necessary but not sufficient • Benefits of EHR integration for clinical research are MAJOR; but costs ALSO • No documented business case yet • No quick wins, but some use cases more feasible • Interaction “one hospital/one sponsor” is not affordable in “production” • “n to m” interfaces needed • OR standard based data exchange • OR third party ? EHR stakeholder workshop – 11th October 2007 5

6. Questions • How to adapt interaction models & processes to ensure benefit at affordable cost • Internal processes changes in providers & sponsors ? • New roles ? • New actors (third party ? IT vendors as enablers ? ) • How to build a common vision across HealthCare to implement these change • Shared understanding • Communication forum ? EHR stakeholder workshop – 11th October 2007 6

7. Focus : Patient Recruitment • Scope • Potential changes • New roles and processes • “Structured” protocol generation & checks before trial • Increase IT skills/collaboration • Third party: which type, which services ? • Decrease constraints related to privacy issues • Decreased cost of technical integration • Provide additional services (act on behalf of caring physician,…) to speed process Protocol feasibility Investigator enrollment Patient enrollment EHR stakeholder workshop – 11th October 2007 7

8. Focus: Data Collection • Scope/Issues • ~80% data collected in clinical care can be re-used • Additional data: integration & ownership ? • Potential changes • New roles and processes • Integration of clinical care and clinical research processes in provider organization ? • How to “seamlessly” adapt EHR for “new” data acquisition ? • Role of CRA versus investigator ? • Third party: which services ? • Decrease costs related to technical integration • New type of CRO ? EHR stakeholder workshop – 11th October 2007 8

9. Focus : Safety • Scope • pre-launch versus post-launch • Signal detection versus Adverse Events reporting • Potential changes • New roles and processes • “validated” information on drugs to ensure correct imputation • Predictive safety: Data mining within existing EHR databases: which skills, which process • Different collaboration mode: sponsors working directly with providers (no need for data exchange) • Impact on pharmacovigilance ? EHR stakeholder workshop – 11th October 2007 9

10. Building Recommendations • Expected deliverable • Issues with current interaction model • Proposal to accelerate effective/secure interaction • Practical next steps • Note: assumption for this stream is that technical and legal hurdle can/will be solved EHR stakeholder workshop – 11th October 2007 10

11. Program – Thursday Afternoon EHR stakeholder workshop – 11th October 2007 11

12. Program – Friday Morning EHR stakeholder workshop – 11th October 2007 12