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

2. EHR stakeholder workshop – 11th October 2007 2 Hospital Clinical Care and Clinical Research 2 separate electronic worlds…. Hospital GPs Office Pharma Industry GPs Office Hospital GPs Office EDC (electronic data capture)

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

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

5. EHR stakeholder workshop – 11th October 2007 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 ?

6. EHR stakeholder workshop – 11th October 2007 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 ?

7. EHR stakeholder workshop – 11th October 2007 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

8. EHR stakeholder workshop – 11th October 2007 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 ?

9. EHR stakeholder workshop – 11th October 2007 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 ?

10. EHR stakeholder workshop – 11th October 2007 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

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

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