European Medical Information Framework tranSMART meeting Paris 7 November 2013

1. EMIF
European Medical Information Framework
Bart Vannieuwenhuyse
7 November 2013
tranSMART meeting Paris

2. 10-Mar-14 2
The IMI is a unique Public-Private Partnership (PPP) between the
pharmaceutical industry represented by the European Federation of
Pharmaceutical Industries and Associations (EFPIA) and the
European Union represented by the European Commission.
tranSMART meeting Paris - 2013

3. Imagine a world where…
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 Researchers can access existing patient-level data to gain new
insights into disease etiologies and to define new treatment
targets…
 We can optimize Clinical R&D by 50% using existing patient level
data…
 New treatments are effective in 95% of patients…
 Where we can continuously monitor the risk/benefit profile of new
therapies using real world data…
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4. Secondary use of health data to
improve clinical research
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The value of healthcare data for secondary uses in clinical research and
development - Gary K. Mallow, Merck, HIMSS 2012

5. Challenges with re-use of patient level
data
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Data gaps
• Missing data elements (e.g. outcomes)
• Studies require details that may not be
routinely collected
• Coding often only at first level (e.g. ICD-
9) therefore missing granularity
• 80% of info stored as unstructured data
Data quality
• Longitudinal coherence
• Coding for administrative reasons (up
– down coding)
• Coding often months after patient
encounter
• Data provenance – who entered the
data?
“Semantics”
• Many standards – many versions
• Complex care – many HCP’s involved
– many hand-overs
• Need to pool data cross sites and
cross different countries
• Pharma focused on CDISC
Privacy
• Clearly a top priority
• Different interpretations by country, by
region – complex
• TRUST
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6. Successful example of data
re-use for research
 RWE of ACHeI
> 2500 patient years of therapy
documented in EHR-system
> 8 fold dataset compared to
Cochrane
 Cost effective
Text mining derivation of service
utilisation and costs.
Created in one month
 Resembles cognitive decline
curve derived from clinical trials
Cholinesterase inhibitors
and Alzheimer’s disease
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-1 0 1 2 3
1618202224
time(years)
MMSEscore
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Lovestone, S. et al - 2012

7. EMIF Vision
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To be the trusted European hub
for health care data intelligence
enabling new insights into
diseases and treatments
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8. Project objectives
EMIF: one project – three topics
1. EMIF-Platform: Develop a framework for evaluating,
enhancing and providing access to human health data
across Europe, to support the two specific topics below
as well as research using human health data in general
2. EMIF-Metabolic: Identify predictors of metabolic
complications in obesity, with the support of EMIF-
Platform
3. EMIF-AD: Identify predictors of Alzheimer’s Disease
(AD) in the pre-clinical and prodromal phase, with the
support of EMIF-Platform
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9. EMIF – platform for modular extension
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EMIF-Metabolic
EMIF-AD
Data Privacy
Analytical tools
Semantic Integration
Information standards
Data access / mgmt
IMI Structure and Network
Research Topics
EMIF governance
Preventionalgorithms
Predictivescreening
Riskstratification
Call xCall x
Riskfactoranalysis
Patientgenerateddata
TBD
EMIF-Platform
Metabolic CNS
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10. Data types in platform:
 Identified categories or “types” of data
 Types:
– Primary care data sets
– Hospital data
– Administrative
– Regional record-linkage systems
– Disease-specific registries
– Biobanks
 Selected representative examples –
 Combined around 48MM subjects from 7 EU countries
 And of course the cohorts from the Research Topics
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11. Data bases “typology”
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12. EMIF systems view
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User
Remote
user 1
Remote
user 2
Remote
user 3
cohorts
Site1Site2Site3
Transactional
environment
Local EMIF solution Cloud-based EMIF solution
Security
Infrastructure
Data
access
Module
Data
access
Module
Data
access
Module
Data
access
Module
Data
access
Module
CommonontologyCommonontologyCommonontology
extract
extract
1:1
Transient
data-pool
Analytical
tools
User
admin
User
admin
User
admin
TTP
TTP
TTP
Q
Q
Q
R
R
R
archive
archive
archive
catalog
catalog
catalog

13. EMIF catalogue - prototype
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14. Cross
Validation
Source of new
epidemiology insights for
patient sub-segments
4
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Researcher
Browsing through directory of “data fingerprints”
Controled data access based on usage rights (Private Remote Research Environments)
CommonDataModel
Analyticaltools/methods
Cohorts
AD
Cohorts
Metabolics
Principle: EMIF will offer a
platform to integrate
available data allowing
pooled analysis
1
EHR datasets
EHR datasets
Data
enrichment
Historic patient data
allowing “roll-back” to
study trajectories
2
Cohorts
AD
Cohorts
Metabolics
Principle: EHR data enables
the search for patients with
specific characteristics to
form new cohorts.
Patient
selection
3

15. Re-using existing solutions
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16. Data being loaded in tranSMART
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4 times the number of subjects in ADNI
Data available for analysis end Oct 2013
Data structure aligned with CDISC
AD MCI
Subjective Memory
impairment
CTL/Controls Total
Cohort 1 259 225 232 716
Cohort 2 160 100 50 80 390
ADNI 1 188 405 229 822
Cohort 3 881 881
Cohort 4 20 14 42 76
Cohort 5 420 420
Total 607 1631 64 1003 3305
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17. Cohort track
• Cohort selection
• AddNeuroMed, Descripa, ADNI, 2 Spanish
cohorts
• Curation process
• Understand documentation & column headers
• Development “Generic Taxonomy” with consistent
variable naming
• Map variables to global taxonomy
• CDISC compliance
• Select priority variables
• Develop mapping files & upload scripts
• Adapt to new upload process in 1.1 release
tranSMART track
• Install PostgreSQL version
• tranSMART release 1.1 installed
• Develop process for data privacy protection
• Sent proposal (based on Barcelona headers) to
Custodix
• Develop process for user authentication
and authorization
• Connect tranSMART to Custodix CIAM
• Sent approval process proposal to Custodix (Jul 10),
awaiting feedback
EMIF tranSMART release 1: independent cohorts
AD Cohort upload into tranSMART
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18. tranSMART platform – analytical
tools
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19. Additional data
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Cohorts MCI Controls Cognition MRI CSF Plasma Genomics
3242 3242 2900 2900
13000
148 4125 4273 358 555 358
150 350 500 470 300 500 500
60 300 360 360 45 360 360
120 120 120 120
100 200 300 300 300 300 300
300 200 500 50 50 300 300
150 150 50 150 150
50 50 50 50 50
50 50 50 50 50
500 500 400 300 300 400
150 150 100 100 150 150
1080 1080 300 409 1080 400
64 20 84 84 64 84 84
300 300 280 300 300
Totals 3052 21607 11659 2872 1718 7149 6302
Access to ~24000 subjects*
important amount of pheno/genotype data available
Involvement pending on scientific agenda
*Associated data providers in consortium

20. More info
 EMIF general
– Bart Vannieuwenhuyse (bvannieu@its.jnj.com)
– Simon Lovestone (simon.lovestone@kcl.ac.uk)
– Johan van der Lei (j.vanderlei@erasmusmc.nl)
 EMIF-Platform
– Johan van der Lei (j.vanderlei@erasmusmc.nl)
– Patrick Genyn (pgenyn1@its.jnj.com)
 EMIF-Metabolics
– Ulf Smith (ulf.smith@medic.gu.se)
– Dawn Waterworth
(Dawn.M.Waterworth@gsk.com)
 EMIF-AD
– Pieter Jelle Visser
(pj.visser@maastrichtuniversity.nl)
– Johannes Streffer (jstreffe@its.jnj.com)
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www.emif.eu