Transcript EHR-Interaction Model - Introduction

EHR integration for clinical
research: toward new
interaction models ?
Isabelle de Zegher
EHR stakeholder workshop – 11th October 2007
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Clinical Care and Clinical Research
2 separate “electronic” worlds….
GP’s Office
GP’s Office
GP’s Office
GP’s Office
Pharma Industry
Hospital
Hospital
EDC
(electronic data
capture)
GP’s Office
Pharma Industry
GP’s Office
GP’s Office
Hospital
Hospital
Pharma Industry
GP’s Office
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Clinical Care and Clinical Research
..who will benefit from electronic data exchange
Patient recruitment
GP’s Office
GP’s Office
Clinical trial simulation
GP’s Office
GP’s Office
New indication identification
Personalized medicine
EDC
(electronic data
capture)
Hospital
Hospital
GP’s Office
Pharma Industry
Pharmacovigilance
Pharmaco-economics
Pharma Industry
GP’s Office
ePrescribing
GP’s Office
Hospital
Hospital
GP’s Office
Predictive safety
Pharma Industry
Pharmaceutical/disease management
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Potential use cases for EHR
Clinical
Research
1. Genetic
Association and
Linkage Analysis
2. Clinical
Validation –
Target,
Biomarker, and
Diagnostic
Clinical
Development
Regulatory /
Safety
3. Clinical Trial Execution
10. Post-Marketing
a. Connect Patients to Trials
b. Data Collection & Mgmt
c. Investigator Services
d. Compliance
e. Placebo Populations
a. Safety /
Adverse Event
Monitoring
Commercial
12. Pharmacoeconomics
13. Marketing
Comparative
Studies
b. Pharmacovigilance
c. P-Epi & Data
Mining
14. Pharmaceutical/
Disease
Management
Programs
Prioritized High-Level Use Cases
4. Clinical Trial Simulation
5. New Indication
Identification
15. e-Prescribing
11. Manufacturer’s
Recall
6. Interim analyses
7. Personalized Medicine – Pharmacogenomics
8. Outcomes Studies
9. Disease and Care Management Modeling
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Source: Splitstream project
“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 ?
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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 ?
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Focus : Patient Recruitment
 Scope
Protocol
feasibility
Investigator
enrollment
Patient
enrollment
 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
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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 ?
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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
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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
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Program – Thursday Afternoon
Time
Title
Overall introduction
14:30 – 14:45 Introduction to the session: participants and expectation
14:45 – 15:05
Lessons learnt on secondary usage of data from the UK NHS CRC study
Author
G. De Moor,
I. de Zegher
J. Parkinson
15:05 – 15:25
Lessons learnt from CRIX, a third party in place in the US: interaction
J. Bland
model, setting up, benefits and concerns of several months of operations
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 R. Thwaites
perspective
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 investigatorclinical 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
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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
G. De Moor,
Consolidated recommendations
I. de Zegher
Practical next steps
12:30
Close of session - LUNCH
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