“Wat kunnen wij leren uit Europese projecten?”

Lessons from European Projects

Jos Devlies, ProRec-BE

MIC2012 2

Issues addressed

November 15, 2012

Definition & Domains of secondary use Main requirements Overview recent and running projects Main problems encountered Conclusions

MIC2012 3

Secondary use of health data

November 15, 2012

“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

November 15, 2012

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

November 15, 2012

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 6November 15, 2012

MIC2012 7November 15, 2012

“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 8November 15, 2012

“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 9November 15, 2012

“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

November 15, 2012

“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

November 15, 2012

MIC2012 12November 15, 2012

“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 13November 15, 2012

“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 14November 15, 2012

“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 15November 15, 2012

“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 16November 15, 2012

“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 17November 15, 2012

“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 18November 15, 2012

“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 19November 15, 2012

“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

November 15, 2012

MIC2012 21November 15, 2012

“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 22November 15, 2012

“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 23November 15, 2012

“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

November 15, 2012

MIC2012 25

Important “agencies”

November 15, 2012

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)

November 15, 2012

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)

November 15, 2012

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

November 15, 2012

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

November 15, 2012