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“Wat kunnen wij leren uit Europese projecten?” Lessons from European Projects

“Wat kunnen wij leren uit Europese projecten?” Lessons from European Projects. Jos Devlies, ProRec-BE. Issues addressed. Definition & Domains of secondary use Main requirements Overview recent and running projects Main problems encountered Conclusions. Secondary use of health data.

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“Wat kunnen wij leren uit Europese projecten?” Lessons from European Projects

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  1. “Wat kunnen wij leren uit Europese projecten?”LessonsfromEuropeanProjects Jos Devlies, ProRec-BE

  2. Issues addressed • Definition & Domains of secondary use • Main requirements • Overview recent and running projects • Main problems encountered • Conclusions MIC2012

  3. Secondary use of health data • “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: • 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: • Feasibility studies • Recruitment • Trial execution MIC2012

  4. Main Requirements • Data availability / accessibility: • Political and ethical context • Patient consent, if not fully anonym • Issue of proportionality • Data quality and reliability: • 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…) MIC2012

  5. Projects: Overview • IMI – Innovative Medicines Initiative • Private Public Partnership • Budget: 2 Billion € • 50/50 EFPIA (Pharma) – European Commission • Separate Calls for proposals • FP7 – Seventh Framework Programme • 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 • Re-using actually clinical data • Addressing: patient safety, cross border care, MIC2012

  6. MIC2012

  7. “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 € MIC2012

  8. “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 € MIC2012

  9. “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 € MIC2012

  10. EMIF • “European Medical Information Framework” • IMI 4th Call • To start • In negotiation process • Keywords: • logistic challenges of an information framework accessible at a level of detail not available yet • Domains: determination of precipitating factors • pre-dementia dysfunction • prodromal Alzheimer • predictors of metabolic complications of adult & paediatric obesitas • Budget: 60.000.000 € MIC2012

  11. Running Projects MIC2012

  12. “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 € MIC2012

  13. “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 € MIC2012

  14. “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 € MIC2012

  15. “Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to Other Indications” • http://www.ponte-project.eu/ • Duration: 2010-2013 • FP7 project • Keywords: drug repositioning, patient recruitment, clinical trials • Budget: 3.276.699€ MIC2012

  16. “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 € MIC2012

  17. “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 € MIC2012

  18. “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 € MIC2012

  19. “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) MIC2012

  20. Past Projects MIC2012

  21. “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 € MIC2012

  22. “Detecting and Eliminating Bacteria Using Information Technology” • www.debugit.eu • FP7-ICT • Duration 2008-2011 • Keywords: • Multi-source data collection (structured and unstructured) • Advanced data mining to detect relevant patterns • Apply knowledge for treatment decision support • Budget: 8.364.797 € MIC2012

  23. “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 MIC2012

  24. Agencies & Registries MIC2012

  25. Important “agencies” • Drug Safety and Effectiveness Network (DSEN) • Canadian Institute of Health Research • http://www.cihr-irsc.gc.ca/e/39389.html • Goal: • 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) • http://www.eu2p.org • IMI project • Duration: 2009-2014 • Education and training programme • Budget: 7.270.886 € MIC2012

  26. Important Agencies (2) • European Drug Utilisation Research Group (EuroDURG) • 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) • http://www.encepp.eu • Embedded in EMA – European Medicines Agency • Goal: strengthen post autorisation monitoring • Scientific society MIC2012

  27. Important Agencies (3) • Observational Medical Outcomes Partnership (OMOP) • 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 MIC2012

  28. Main problems encountered • Data quality is still the main issue • Still much free text and unstructured data • Absence of professional tools to interpret text documents • Missing data that are insufficiently granular • Semantic interoperability is in its childhood • 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 • Misused in order to “protect”.. what? MIC2012

  29. Conclusion MIC2012

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