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EMIFEuropean Medical Information Framework
Bart Vannieuwenhuyse7 November 2013
tranSMART meeting Paris
Apr 10, 2023
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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
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Imagine a world where…
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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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
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Challenges with re-use of patient level data
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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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
tranSMART meeting Paris - 2013
-1 0 1 2 3
1618
2022
24
time(years)
MM
SE
sco
re
Lovestone, S. et al - 2012
Apr 10, 2023
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EMIF Vision
To be the trusted European hub for health care data
intelligence enabling new insights into diseases and
treatments
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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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EMIF – platform for modular extension
EM
IF -
Met
abo
lic
EM
IF -
AD
Data Privacy
Analytical tools
Semantic Integration
Information standards
Data access / mgmt
IMI Structure and Network
Research Topics
EMIF governance
Pre
ve
nti
on
alg
ori
thm
s
Pre
dic
tiv
e s
cre
en
ing
Ris
k s
tra
tifi
ca
tio
n
Call xCall x
Ris
k f
ac
tor
an
aly
sis
Pa
tie
nt
ge
ne
rate
d d
ata
TBD
EM
IF -
Pla
tfo
rm
Metabolic CNS
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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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Data bases “typology”
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EMIF systems view
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User
Remote user 1
Remote user 2
Remote user 3
cohorts
Site
1S
ite 2
Site
3
Transactional environment
Local EMIF solution Cloud-based EMIF solution
Security Infrastructure
Data accessModule
Data accessModule
Data accessModule
Data accessModule
Data accessModule
Com
mon
ont
olog
yCo
mm
on o
ntol
ogy
Com
mon
ont
olog
yextract
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
Apr 10, 2023
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EMIF catalogue - prototype
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Cross Validation
Source of new epidemiology insights for patient sub-segments
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Researcher
Browsing through directory of “data fingerprints”
Controled data access based on usage rights (Private Remote Research Environments)
Com
mon
Dat
a M
odel
Anal
ytica
l too
ls /
met
hods
Cohorts
AD
Cohorts
Metabolics
Principle: EMIF will offer a platform to integrate available data allowing pooled analysis
1
EHR datasetsEHR 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
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Re-using existing solutions
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Data being loaded in tranSMART
4 times the number of subjects in ADNI
Data available for analysis end Oct 2013Data 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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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
Apr 10, 2023
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tranSMART platform – analytical tools
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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 availableInvolvement pending on scientific agenda
*Associated data providers in consortium
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More info
EMIF general– Bart Vannieuwenhuyse ([email protected])– Simon Lovestone ([email protected])– Johan van der Lei ([email protected])
EMIF-Platform– Johan van der Lei ([email protected])– Patrick Genyn ([email protected])
EMIF-Metabolics– Ulf Smith ([email protected])– Dawn Waterworth
EMIF-AD– Pieter Jelle Visser
([email protected])– Mike Krams ([email protected])
tranSMART meeting Paris - 2013
www.emif.eu