Transcript information framework - ProRec-BE

“Wat kunnen wij leren uit Europese
projecten?”
Lessons from European Projects
Jos Devlies, ProRec-BE
Issues addressed
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Definition & Domains of secondary use
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Main requirements
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Overview recent and running projects
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Main problems encountered
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Conclusions
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Secondary use of health data
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“Secondary use of health data applies personal health
information(PHI) for uses outside of direct health care
delivery.” (Charles Safran et al., J.Am.Med.Inform.Assoc. 2007 Jan-Feb; 14 (1): 1-9)
Main domains:
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Research: to expand knowledge about diseases & treatments
Payment and Management : see tomorrow
Support public health: epidemiology, prevention
Efficiency and effectiveness of care: outcome analysis
Patient safety: pharmacovigilance
Support care product development / Clinical trials:
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Feasibility studies
Recruitment
Trial execution
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Main Requirements
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Data availability / accessibility:
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Data quality and reliability:
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Political and ethical context
Patient consent, if not fully anonym
Issue of proportionality
Correct and validated concepts for a given condition at a given
moment
Sufficiently granularly documented, context of origin included
Reliable and sufficiently structured
Technical interoperability: portability: syntax
Semantic interoperability: different standards, multilingual, different
“schools” (staging, units, etc…)
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Projects: Overview
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IMI – Innovative Medicines Initiative
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FP7 – Seventh Framework Programme
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Private Public Partnership
Budget: 2 Billion €
50/50 EFPIA (Pharma) – European Commission
Separate Calls for proposals
Addressing different domains: ex. ICT, Health, Transport etc….
For us: mainly DG Infso, now DG Connect, also DG Industry
Different “vehicles”: large IP projects, STREP projects, Netwrok of
Excellence, Thematic Networks, Joint Actions (with Member states)
More permanent Institutes & Registries
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Re-using actually clinical data
Addressing: patient safety, cross border care,
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“Electronic Health Record systems for Clinical Research”
http://www.ehr4cr.eu
Duration: 2011-2015
IMI Project
Keywords: multicentric platform for protocol feasibility,
patient recruitment, trial execution, integrate EHR and
EDC, business model
Budget: 16.051.512 €
November 15, 2012
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“Drug Disease Model Resources”
Focus: model based drug development (MBDD)
www.ddmore.eu
IMI project
Duration: 2011 - 2016
Keywords: unified Model Definition Language, efficient
exchange and reuse of knowledge, collaborative drug and
disease modelling and simulation, metadata standards for
system-to-system interchange of models and data.
Budget: 21.165.061 €
November 15, 2012
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“Pharmacoepidaemiological Research on Outcomes of
Therapeutics by a European Consortium”
Coordinated by European Medicines Agency
www.imi-protect.eu
IMI project
Duration: 2009 – 2014
Keywords: early detection ADR, assessment of adverse
drug reactions, representation of benefits and risks of
medicinal products, signal detection
Budget: 29.810.613 €
November 15, 2012
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“European Medical Information Framework”
IMI 4th Call
To start
In negotiation process
Keywords:
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logistic challenges of an information framework accessible at a level
of detail not available yet
Domains: determination of precipitating factors
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pre-dementia dysfunction
prodromal Alzheimer
predictors of metabolic complications of adult & paediatric obesitas
Budget: 60.000.000 €
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Running Projects
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“Develop a scalable and sustainable pan-European
organisational and governance process for semantic
interoperability of clinical and biomedical knowledge”
http://semantichealthnet.eu
FP7 – Network of Excellence
Duration: 2011 –2014
Network of Excellence
Keywords: eHealth infostructure, European Virtual
Organisation for Semantic Interoperability, chronic heart
failure, cardiovascular prevention
Budget: 3.222.380 €
November 15, 2012
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“Patient Registries Initiative”
Joint Action
www.patientregistries.eu
Duration: 2012-2014
Keywords: comparable and coherent patient registries
governance, analysis for public health and research
Budget: 3.200.000 €
November 15, 2012
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“Translational Research and Patients Safety in Europe”
Duration : 2010 – 2015
http://www.transformproject.eu
FP7-ICT project : ICT for Patient Safety
Keywords: primary care, diagnostic decision support,
identification of patient eligible for research, controlled
vocabulary, interoperability of EHR data
Budget: 9.006.339 €
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“Efficient Patient Recruitment for Innovative Clinical
Trials of Existing Drugs to Other Indications”
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http://www.ponte-project.eu/
Duration: 2010-2013
FP7 project
Keywords: drug repositioning, patient recruitment, clinical
trials
Budget: 3.276.699€
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“Enabling information reuse by linking clinical research
and care”
http://eurecaproject.eu
FP7-ICT project
Duration: 2012 - 2015
Keywords: secondary use of care data, efficient
recruitment for clinical trials, breast cancer
Budget: 13.397.801 €
November 15, 2012
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“Integrative Cancer Research Through Innovative
Biomedical Infrastructure”
http://www.fp7-integrate.eu
Duration: 2011-2014
FP7-ICT project
Keywords: shared repository of clinical trial data, breast
cancer, predictive models, identify biomarkers, patient
screening in oncology clinical trials
Budget: 5.803.000 €
November 15, 2012
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“Scalable, Standard based Interoperability Framework for
Sustainable Proactive Post Market Safety Studies”
http://www.salusproject.eu
Duration: 2012-2015
FP7-ICT
Keywords: post market safety studies, pharmacovigilance
Budget: 5.077.781 €
November 15, 2012
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“From data sharing and integration via VPH models to
personalised medicine”.
http://www.p-medicine.eu
FP7 – ICT
Duration: 2011-2015
Keywords: individualised treatment for patients with
cancer, multi-level data collection (trials and clinical
information), interdisciplinary data analysis
Budget: 13.329.908 € (funding)
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Past Projects
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“Exploring and Understanding Adverse Drug Reactions by
Integrative Mining of Clinical Records and Biomedical
Knowledge”
FP7-ICT Collaborative Project
www.alert-project.org
Feb. 2008 – Jan 2012
Keywords: ADR, Mining of EHR data
Budget: 5.880.000 €
November 15, 2012
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“Detecting and Eliminating Bacteria Using Information
Technology”
www.debugit.eu
FP7-ICT
Duration 2008-2011
Keywords:
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Multi-source data collection (structured and unstructured)
Advanced data mining to detect relevant patterns
Apply knowledge for treatment decision support
Budget: 8.364.797 €
November 15, 2012
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“Patient Safety through Intelligent Procedures in
medication”
http://www.psip-project.eu/
FP7 – ICT
Duration: 2008-2011
Keywords: ADE, medication errors due to human factors,
data mining,
Budget: 10.175.011
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Agencies & Registries
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Important “agencies”
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Drug Safety and Effectiveness Network (DSEN)
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Canadian Institute of Health Research
http://www.cihr-irsc.gc.ca/e/39389.html
Goal:
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increase evidence on drug safety and effectiveness to regulators and
other stakeholders
Increase capacity for high-quality post-market research
European Programme in Pharmacovigilance and
Pharmcoepidemiology (Eu2P)
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http://www.eu2p.org
IMI project
Duration: 2009-2014
Education and training programme
Budget: 7.270.886 €
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Important Agencies (2)
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European Drug Utilisation Research Group (EuroDURG)
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Part of the International Society of Pharmacoepidemiology
Participates in scientific projects
Discuss on drug utilisation and on quality and cost containment of
therapy.
http://www.pharmacoepi.org/eurodurg/presentation.cfm
European Network of Centres for pharmaco-epidemiology
and pharmacovigilance (ENCePP)
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http://www.encepp.eu
Embedded in EMA – European Medicines Agency
Goal: strengthen post autorisation monitoring
Scientific society
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Important Agencies (3)
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Observational Medical Outcomes Partnership (OMOP)
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http://omop.fnih.org
US project – Foundation for the National Institutes of Health
Public-private partnership to help to improve the monitoring
of drugs for safety.
Keywords: observational data, common data model, develop
and test methods to detect drug safety issues over time
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Main problems encountered
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Data quality is still the main issue
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Semantic interoperability is in its childhood
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Still much free text and unstructured data
Absence of professional tools to interpret text documents
Missing data that are insufficiently granular
Competing / conflicting “commercial” standards
Insufficiently standardised metadata (nature, context,…)
Multi-lingual and multi-cultural issues nearly not addressed
Data privacy is still a fuzzy concept
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Misused in order to “protect”.. what?
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Conclusion
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