ehr integration for clinical research: toward new interaction models ?

EHR stakeholder workshop – 11th October 2007 1

EHR integration for clinical research: toward new interaction models ? Isabelle de Zegher

EHR stakeholder workshop – 11th October 2007 2

Hospital

Clinical Care and Clinical Research2 separate “electronic” worlds….

Hospital

GP’s Office

Pharma Industry

Pharma Industry

Pharma Industry

GP’s Office

GP’s Office

GP’s Office

Hospital

Hospital

GP’s Office

GP’s Office

GP’s Office

GP’s Office

EDC(electronic data

capture)

EHR stakeholder workshop – 11th October 2007 3

HospitalHospital

GP’s Office

Pharma Industry

Pharma Industry

Pharma Industry

GP’s Office

GP’s Office

GP’s Office

Hospital

Hospital

GP’s Office

GP’s Office

GP’s Office

GP’s 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

EHR stakeholder workshop – 11th October 2007 4

Potential use cases for EHR

12. Pharmaco-economics

13. Marketing Comparative Studies

14. Pharmaceutical/ Disease ManagementPrograms

15. e-Prescribing

10. Post-Marketing

a. Safety / Adverse Event Monitoring

b. Pharmaco-vigilance

c. P-Epi & Data Mining

11. Manufacturer’s Recall

3. Clinical Trial Execution

a. Connect Patients to Trials

b. Data Collection & Mgmt

c. Investigator Services

d. Compliance

e. Placebo Populations

4. Clinical Trial Simulation

5. New Indication Identification

6. Interim analyses

1. Genetic Association and Linkage Analysis

2. Clinical Validation –Target, Biomarker, and Diagnostic

CommercialRegulatory / Safety

Clinical Development

Clinical Research

7. Personalized Medicine – Pharmacogenomics

8. Outcomes Studies

9. Disease and Care Management Modeling

Prioritized High-Level Use Cases

12. Pharmaco-economics

13. Marketing Comparative Studies

14. Pharmaceutical/ Disease ManagementPrograms

15. e-Prescribing

10. Post-Marketing

a. Safety / Adverse Event Monitoring

b. Pharmaco-vigilance

c. P-Epi & Data Mining

11. Manufacturer’s Recall

3. Clinical Trial Execution

a. Connect Patients to Trials

b. Data Collection & Mgmt

c. Investigator Services

d. Compliance

e. Placebo Populations

4. Clinical Trial Simulation

5. New Indication Identification

6. Interim analyses

1. Genetic Association and Linkage Analysis

2. Clinical Validation –Target, Biomarker, and Diagnostic

CommercialRegulatory / Safety

Clinical Development

Clinical Research

7. Personalized Medicine – Pharmacogenomics

8. Outcomes Studies

9. Disease and Care Management Modeling

Prioritized High-Level Use Cases

Source: Splitstream project

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 ?

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 ?

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

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 ?

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 ?

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

EHR stakeholder workshop – 11th October 2007 11

Program – Thursday AfternoonTime Title Author Overall introduction 14:30 – 14:45 Introduction to the session: participants and expectation G. De Moor,

I. de Zegher 14:45 – 15:05

Lessons learnt on secondary usage of data from the UK NHS CRC study J. Parkinson

15:05 – 15:25

Lessons learnt from CRIX, a third party in place in the US: interaction model, setting up, benefits and concerns of several months of operations

J. Bland

Focus on Patient recruitment. Patient recruitment: from today’s paper based process to “24 hours recruitment”” is a technology supported by process changes enough or do we need a third party to solve legal issues and technical heterogeneity. 15:25 – 15:45 Identifying and recruiting patients for clinical trials in the future: a pharma

perspective R. Thwaites

15:45 – 16:15 Hospital/Health care perspective J. van der Lei 16:30 – 16:50 IT perspective C. Mead 16:50 – 17:15 Discussion and recommendations for actions I. de Zegher,

G. De Moor, Focus on Electronic data capture. Can EHR replace the need for eCRF, what is the impact on the investigator-clinical monitor roles 17:15 – 17:35 A detail on the process: pharma perspective H. Donovan 17:35 – 17:45 Hospital/Health care perspective C. Le Bozec 17:45 – 18:05 IT vendors perspective JF Penciolelli

EHR stakeholder workshop – 11th October 2007 12

Program – Friday Morning

Time Title Author Focus on Electronic data capture. Can EHR replace the need for eCRF, what is the impact on the investigator-clinical monitor roles 08:30 – 09:00 Discussion and recommendations for actions G. De Moor,

I. de Zegher Focus on Safety. Availability of EHR database and data warehouse: a new safety model ? impact on the current pharmacovigilance models ? 09:00 – 09:20 A detail on the process: pharma perspective S. Markel-Fox 09:20 – 09:40 Hospital/Health care perspective C. Lovis 09:40 – 10:00 IT vendors perspective Sarah Payne 10:00 – 10:20 Authorities perspective T. Buxton 10:20 – 10:40 BREAK 10:40 – 11:10 Discussion and recommendations for actions on safety I. de Zegher,

G. De Moor Consolidated recommendations (Identify person responsible for reporting during plenary) 11:10 – 12:30 Key messages from the different focus areas

Consolidated recommendations Practical next steps

G. De Moor, I. de Zegher

12:30 Close of session - LUNCH