emif_transmart meeting paris_7 november 2013
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EMIF European Medical Information Framework
Bart Vannieuwenhuyse 7 November 2013
tranSMART meeting Paris
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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
Imagine a world where…
10-Mar-14 3
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
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
tranSMART meeting Paris - 2013
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
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Lovestone, S. et al - 2012
EMIF Vision
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To be the trusted European hub for health care data intelligence
enabling new insights into diseases and treatments
tranSMART meeting Paris - 2013
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
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EMIF
- M
etab
olic
EMIF
- AD
Data Privacy
Analytical tools
Semantic Integration
Information standards
Data access / mgmt
IMI Structure and Network
Research Topics
EMIF governance
Prev
entio
n al
gorit
hms
Pred
ictiv
e sc
reen
ing
Ris
k st
ratif
icat
ion
Call x Call x
Ris
k fa
ctor
ana
lysi
s
Patie
nt g
ener
ated
dat
a
TBD
EMIF
- Pl
atfo
rm
Metabolic CNS
tranSMART meeting Paris - 2013
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
1
Site
2
Site
3
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
Com
mon
ont
olog
y Co
mm
on o
ntol
ogy
Com
mon
ont
olog
y 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
EMIF catalogue - prototype
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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)
Com
mon
Dat
a M
odel
Anal
ytic
al to
ols /
met
hods
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
Re-using existing solutions
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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
tranSMART meeting Paris - 2013
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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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 available Involvement pending on scientific agenda
*Associated data providers in consortium
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
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