EMIF
European Medical Information Framework

Bart Vannieuwenhuyse
7 November 2013
tranSMART meeting Paris
The IMI is a unique Public-Private Partnership (PPP) between the
pharmaceutical industry represented by the European Feder...
Imagine a world where…
 Researchers can access existing patient-level data to gain new

insights into disease etiologies ...
Secondary use of health data to
improve clinical research

The value of healthcare data for secondary uses in clinical res...
Challenges with re-use of patient level
data
Data gaps

Data quality

• Missing data elements (e.g. outcomes)

• Longitudi...
Successful example of data
re-use for research

24

Cholinesterase inhibitors
and Alzheimer’s disease
 RWE of ACHeI

 Co...
EMIF Vision
To be the trusted European hub
for health care data intelligence
enabling new insights into
diseases and treat...
Project objectives
EMIF: one project – three topics
1. EMIF-Platform: Develop a framework for

evaluating, enhancing and p...
EMIF – platform for modular extension

Risk factor analysis

EMIF - AD

Call x

TBD
Predictive screening

CNS

Call x
Risk...
Data types in platform:
 Identified categories or “types” of data

 Types:
–
–
–
–
–
–

Primary care data sets
Hospital ...
Data bases “typology”

tranSMART meeting Paris - 2013

12-Nov-13

11
Data
access
Module

Site 2

Data
access
Module

Data
access
Module

Common ontology

Site 1

Data
access
Module

Common on...
EMIF catalogue - prototype

tranSMART meeting Paris - 2013

12-Nov-13

13
Researcher

Browsing through directory of “data fingerprints”
Controled data access based on usage rights (Private Remote ...
Re-using existing solutions

tranSMART meeting Paris - 2013

12-Nov-13

15
Data being loaded in tranSMART
AD

MCI

Cohort 1

259

225

Cohort 2

160

100

ADNI 1

188

Subjective Memory
impairment
...
AD Cohort upload into tranSMART
Cohort track

tranSMART track

• Cohort selection

• Install PostgreSQL version

• AddNeur...
tranSMART platform – analytical
tools

tranSMART meeting Paris - 2013

12-Nov-13

18
Additional data
Cohorts

MCI

Controls

Cognition

3242

3242

148

13000
4125

4273

358

150

350

500

470

300

60

30...
More info
 EMIF general
–
–
–

Bart Vannieuwenhuyse (bvannieu@its.jnj.com)
Simon Lovestone (simon.lovestone@kcl.ac.uk)
Jo...
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tranSMART Community Meeting 5-7 Nov 13 - Session 5: EMIF (European Medical Information Framework)

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tranSMART Community Meeting 5-7 Nov 13 - Session 5: EMIF (European Medical Information Framework)
EMIF (European Medical Information Framework)
Bart Vannieuwenhuyse, Jannsen
An update will be provided on EMIF (European Medical Information Framework) an IMI project focused on the reuse of existing patient level data to enable more efficient research. Besides a general introduction to the project, there will be specific attention to the work done around tranSMART in the EMIF-AD research topic. A brief description of achievements to-date and expected overall outcome of the EMIF project will be discussed.

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tranSMART Community Meeting 5-7 Nov 13 - Session 5: EMIF (European Medical Information Framework)

  1. 1. EMIF European Medical Information Framework Bart Vannieuwenhuyse 7 November 2013 tranSMART meeting Paris
  2. 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 12-Nov-13 2
  3. 3. 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… tranSMART meeting Paris - 2013 12-Nov-13 3
  4. 4. Secondary use of health data to improve clinical research The value of healthcare data for secondary uses in clinical research and development - Gary K. Mallow, Merck, HIMSS 2012 tranSMART meeting Paris - 2013 12-Nov-13 4
  5. 5. Challenges with re-use of patient level data Data gaps Data quality • Missing data elements (e.g. outcomes) • Longitudinal coherence • Studies require details that may not be routinely collected • Coding for administrative reasons (up – down coding) • Coding often only at first level (e.g. ICD9) therefore missing granularity • Coding often months after patient encounter • 80% of info stored as unstructured data • Data provenance – who entered the data? “Semantics” Privacy • Many standards – many versions • Clearly a top priority • Complex care – many HCP’s involved – many hand-overs • Different interpretations by country, by region – complex • Need to pool data cross sites and cross different countries • TRUST • Pharma focused on CDISC tranSMART meeting Paris - 2013 12-Nov-13 5
  6. 6. Successful example of data re-use for research 24 Cholinesterase inhibitors and Alzheimer’s disease  RWE of ACHeI  Cost effective 18 Text mining derivation of service utilisation and costs. Created in one month 20 MMSE score 22 > 2500 patient years of therapy documented in EHR-system > 8 fold dataset compared to Cochrane curve derived from clinical trials Lovestone, S. et al - 2012 16  Resembles cognitive decline -1 0 tranSMART meeting Paris - 2013 1 time(years) 2 12-Nov-13 3 6
  7. 7. EMIF Vision To be the trusted European hub for health care data intelligence enabling new insights into diseases and treatments tranSMART meeting Paris - 2013 12-Nov-13 7
  8. 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 EMIFPlatform 3. EMIF-AD: Identify predictors of Alzheimer’s Disease (AD) in the pre-clinical and prodromal phase, with the support of EMIF-Platform tranSMART meeting Paris - 2013 12-Nov-13 8
  9. 9. EMIF – platform for modular extension Risk factor analysis EMIF - AD Call x TBD Predictive screening CNS Call x Risk stratification Patient generated data Research Topics EMIF - Metabolic Metabolic Prevention algorithms EMIF governance EMIF - Platform Data Privacy Analytical tools Semantic Integration Information standards Data access / mgmt IMI Structure and Network tranSMART meeting Paris - 2013 12-Nov-13 9
  10. 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 tranSMART meeting Paris - 2013 12-Nov-13 10
  11. 11. Data bases “typology” tranSMART meeting Paris - 2013 12-Nov-13 11
  12. 12. Data access Module Site 2 Data access Module Data access Module Common ontology Site 1 Data access Module Common ontology EMIF systems view R archive Q catalog extract TTP R User admin Remote user 1 User admin Remote user 2 User admin Remote user 3 archive Q catalog extract TTP Site 3 Data access Module cohorts User Transactional environment Common ontology Transient data-pool R Analytical tools archive Q 1:1 catalog TTP Local EMIF solution Cloud-based EMIF solution Security Infrastructure tranSMART meeting Paris - 2013 12-Nov-13 12
  13. 13. EMIF catalogue - prototype tranSMART meeting Paris - 2013 12-Nov-13 13
  14. 14. Researcher Browsing through directory of “data fingerprints” Controled data access based on usage rights (Private Remote Research Environments) AD Metabolics Metabolics 3 Common Data Model Cohorts Cohorts Cohorts Cohorts Principle: EMIF will offer a platform to integrate available data allowing pooled analysis Principle: EHR data enables the search for patients with specific characteristics to form new cohorts. Data enrichment Patient selection 4 Cross Validation 2 Analytical tools / methods 1 AD EHR datasets EHR datasets Historic patient data allowing “roll-back” to study trajectories Source of new epidemiology insights for patient sub-segments tranSMART meeting Paris - 2013 12-Nov-13 14
  15. 15. Re-using existing solutions tranSMART meeting Paris - 2013 12-Nov-13 15
  16. 16. Data being loaded in tranSMART AD MCI Cohort 1 259 225 Cohort 2 160 100 ADNI 1 188 Subjective Memory impairment 405 Cohort 3 20 716 80 390 229 822 881 Cohort 4 Total 232 50 CTL/Controls 881 14 Total 607 1631 64 76 420 Cohort 5 42 420 1003 3305 4 times the number of subjects in ADNI Data available for analysis end Oct 2013 Data structure aligned with CDISC tranSMART meeting Paris - 2013 12-Nov-13 16
  17. 17. AD Cohort upload into tranSMART Cohort track tranSMART track • Cohort selection • Install PostgreSQL version • AddNeuroMed, Descripa, ADNI, 2 Spanish cohorts • tranSMART release 1.1 installed • Develop process for data privacy protection • 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 • 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 • Adapt to new upload process in 1.1 release EMIF tranSMART release 1: independent cohorts tranSMART meeting Paris - 2013 12-Nov-13 17
  18. 18. tranSMART platform – analytical tools tranSMART meeting Paris - 2013 12-Nov-13 18
  19. 19. Additional data Cohorts MCI Controls Cognition 3242 3242 148 13000 4125 4273 358 150 350 500 470 300 60 300 120 360 120 360 120 100 300 200 200 300 500 300 50 150 MRI Plasma Genomics 2900 2900 555 358 500 500 45 360 120 360 300 50 300 300 300 300 50 150 CSF 150 150 50 50 50 50 50 50 50 50 50 500 500 400 300 300 400 150 1080 150 1080 100 409 64 150 1080 84 300 150 400 84 300 1718 7149 6302 50 64 300 Totals 20 84 300 100 300 84 280 3052 21607 11659 2872 Access to ~24000 subjects* important amount of pheno/genotype data available Involvement pending on scientific agenda *Associated data providers in consortium tranSMART meeting Paris - 2013 12-Nov-13 19
  20. 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) www.emif.eu  EMIF-AD – – Pieter Jelle Visser (pj.visser@maastrichtuniversity.nl) Mike Krams (mkrams@its.jnj.com) tranSMART meeting Paris - 2013 12-Nov-13 20

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