“Breaking Barriers: Liberating Health Data to accelerate High Quality Clinical Research” Prof. Dr. Georges De Moor Monte Carlo, 21.10.13 Prof. Dr. G. De Moor 1 of 66 Dept. of Medical Informatics and Statistics, Ghent University, Belgium & - RAMIT - European Institute for Health Records - EuroRec - - Custodix -
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Evolution 2013: Prof. Dr. Georges De Moor, EuroRec on Liberating Health Data to accelerate High Quality Clinical Research
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“Breaking Barriers: Liberating Health Data to accelerate High Quality Clinical Research”
Prof. Dr. Georges De Moor
Monte Carlo, 21.10.13 Prof. Dr. G. De Moor 1 of 66
Dept. of Medical Informatics and Statistics,Ghent University, Belgium & - RAMIT -
European Institute for Health Records - EuroRec -
- Custodix -
EuroRec
• The EuroRec Institute (EuroRec) is a European
independent not-for-profit organisation, whose main
purpose is promoting the real use of high quality
Electronic Health Record systems (EHRs) in Europe.
• EuroRec is overarching a permanent network of national
ProRec centres and provides services to industry
Monte Carlo, 21.10.13 Prof. Dr. G. De Moor 2 of 66
ProRec centres and provides services to industry
(developers and vendors), healthcare systems and
providers (buyers), policy makers and patients.
• EuroRec produced and maintains a substantial resource
with ± 1700 functional quality criteria for EHR-systems,
categorised, indexed and translated in 19 European
languages. The EuroRec Use Tools help users to handle
this resource.
• Amount of information to support medicine and healthcare is exploding
• ICT is transforming both biomedical research and healthcare (e-Health)
Introduction
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• The way scientists ‘do science’ is changing (a revolution)
• Electronic Health Records (EHRs) are gaining - in combination with emerging
infrastructures - an important novel supporting role for clinical research
Capture, Combine, Co-interpret Data
from diverse Information Sources
Population Registries,
Clinical Trial Data-Bases,
Bio-Bank data
Care Pathways Systems,
Decision Support Systems,
Trends and Alerting Systems
Data
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EHRs, PHRs, Ancillary DBs
and other Clinical Applications
Mobile Devices,
Apps (medical/well-being)
Bio-sensors and Body ImplantsSocial Networks
DataInformationKnowledge
Capture, Combine, Co-interpret Data
from diverse Information Sources
Clinical data
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“-Omics” data
(genomics, proteomics, metabolomics…)
Environmental data
(pollution, nutrition…)
Leveraging Knowledge Discovery
Data
Information
interpretation
interpretation
(Wisdom)
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Knowledge
Decision
Action
Electronic Health Records & systems: Trends
• Patient-centered (gatekeeper?), life long records
• Highly relevant to customers (addresses unmet needs)
• Substantiated with quantified value (versus current standards), e.g.
• Cost-benefit assessment (“Value for money”)
• Budgetary impact
A Value Proposition is Central to Any Business Model
EHR4CR Business model
The EHR4CR business model:
• Specify in detail the product and service offering;
• Include analyses and an impact analysis on multiple stakeholders;
• Deliver a self-sustaining economic model including sensitivity analysis;
• Define appropriate governance arrangements for the platform services and for pan-European EHR4CR networks;
Define operating procedures and trusted third party service
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• Define operating procedures and trusted third party service requirements;
• Identify the value proposition and incentives for each of the key players and stakeholders impacted by EHR4CR;
• Define accreditation and certification plans/programs for EHR systems capable of interfacing with the platform;
• Provide a framework to define public and private sector roles in reusing EHRs for clinical research;
• Define a roadmap for pan-European/global adoption and for funding future developments.
Vision, Mission, Values
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Deliver Value
Create Value
Business Model Framework Uses Nine Building Blocks
EHR4CR Outputs
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Source: ICTechnoloage 2013
Study on Business and Financing Models Related to ICT for Ageing Well
Adapted from Osterwalder & Pigneur 2010
CaptureValue
Stakeholders
1. Patients2. Clinicians (in Primary, Secondary and Tertiary Care settings)3. Clinical Investigators4. Contract Research Organisations (CROs)5. Pharmaceutical Industry6. Hospital Administrators
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6. Hospital Administrators7. Academia8. EHR Systems Vendors9. Trusted Third Parties (TTPs) and Trusted Services Providers
(TSPs)10. Health Authorities11. Health Care Planners12. Regulators
Benefits by stakeholder segment
• Patient perspective
– Improved mechanisms for inclusion in clinical trials
– Faster access to innovative and safer treatments
• Academic perspective
– Increased efficiency of academic clinical studies
– Enabled multi-center protocol designs
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– Enabled multi-center protocol designs
• Pharmaceutical perspective
– Increased clinical trial efficiency
– Observational and outcomes research in real-world settings
• Healthcare perspective
– Enabling clinician participation in more clinical trials
– Adding an additional revenue stream.
• Patients: EHR-integrated research platforms will provide a secure environment
to share health data and thus for advancing clinical research
• Research Community: optimise research, processes and timelines
• Pharmaceutical Industry: maximize R&D value chain
• Contract Research Organisations: maximise value to customers and diversify
revenue streams
Benefits (1)
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revenue streams
• Clinical investigators & Physicians: enable participation in a larger number of
clinical trials
• Regulatory Agencies: generate clinical evidence more rapidly for assisting
regulatory decision-making
• Public & Private Payers: enable further cost-effectiveness research
• Hospitals & healthcare organisations: enhance EHR data quality, management
reporting, performance benchmarking, image and revenues …
• Academic Centres: generate more research opportunities and funding
• ICT industry: open new business opportunities
Benefits (2)
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In general: the reuse of EHR data for clinical research will optimise clinical
development towards achieving faster access to innovative medicines
Stakeholders and Forces in place
Who can influence? … the one who …
pays / invests ?
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regulates ?
knows?
(other: e.g. the one who owns the data?…)
Business Model Innovation & Simulation
Forecasts the financial results for a EHR4CR service provider
• Based on estimated expenses and revenues
• Balance sheets (revenues minus expenses)
• Profitability ratio (revenues divided by expenses)
EHR4CR BMI and CBA
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Cost-Benefit Assessment
Establishes the value of EHR4CR services versus current standards
• Estimated costs and benefits from the perspective of the primary payer
• Uses the perspective of a service provider over a 5-year time horizon
• Pharmaceutical industry/CROs and clinical research units as primary customers
• Based on willingness to pay and current market value (EU market)
• Conservative assumptions generated by multidisciplinary expert task force
• “Monte Carlo” simulations (10,000 iterations across all distribution ranges) as robust
probabilistic sensitivity analysis
Business Model Simulation Supports Financial Sustainability
EHR4CR Outputs
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Estimated Average of 3.9M € (yr1) - 27.3M € (yr 5) Estimated Average of 1.78 (yr1) - 6.3 (yr5)
• Perspective
– Service Provider
• Time Horizon
– 5 years (incl. yearly estimates)
• Customer Segments
– Tier I: PRO (Pharmaceutical Research)
– Tier II: CRO (Contract Research Organisations)
– Tier III: CRU (Clinical Research Units)
• EHR4CR Services
– EHR4CR platform annual registration fee
– EHR4CR fee per service (% per-pt cost/CT)
• Protocol feasibility: 2-4%
• Patient identification: 3-5%
• Study conduct: 5-10%
• SAE Reporting: 0.5%
• Estimated SP Yearly Target Objectives
Business Model Simulation Market Assumptions
EHR4CR Outputs
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– Tier III: CRU (Clinical Research Units)
• EU Market Landscape
– 5-yr Estimated # CT(Phase II-IV) in Europe
– Est. 250-500pts /CT
– 5-yr EHR4CR Market Uptake: 5-10%
– Est. # of Service Providers: 5-15
• Estimated CT Costs
– Per-pt cost/CT: ~10,000 €/pt
• EHR Data Access Cost
– 1.0-2.5% per-pt cost/CT/yr (fixed fee model)
– Includes certification/accreditation margins
• Estimated SP Yearly Target Objectives
(applied to an estimated market penetration of 5-10%)
– Protocol Feasibility
• Yr 1-2: 3-7%
• Yr 3-5: 7-20%
– Patient Identification
• Yr 1-2: 15-30%
• Yr 3-5: 30-60%
– Study Conduct/SAE
• Yr 1-2: 1-5%
• Yr 3-5: 5-30%
EHR4CR Outputs
Objective: To establish the value of EHR4CR services compared to current practices
Perspective: Pharmaceutical industry (primary payer)