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

EMIFEuropean Medical Information Framework

Bart Vannieuwenhuyse7 November 2013

tranSMART meeting Paris

Apr 10, 2023

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

Apr 10, 2023

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…


Apr 10, 2023

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

Apr 10, 2023

5

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


Apr 10, 2023

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


-1 0 1 2 3

1618

2022

24

time(years)

MM

SE

sco

re

Lovestone, S. et al - 2012

Apr 10, 2023

7

EMIF Vision

To be the trusted European hub for health care data

intelligence enabling new insights into diseases and

treatments


Apr 10, 2023

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


Apr 10, 2023

9

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


Apr 10, 2023

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


Apr 10, 2023

11

Data bases “typology”


Apr 10, 2023

12

EMIF systems view


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

13tranSMART meeting Paris - 2013

EMIF catalogue - prototype

Apr 10, 2023

14

Cross Validation

Source of new epidemiology insights for patient sub-segments

4


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

Apr 10, 2023

15

Re-using existing solutions


Apr 10, 2023

16

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


Apr 10, 2023

17tranSMART 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

Apr 10, 2023

18

tranSMART platform – analytical tools


Apr 10, 2023

19

Additional data


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

Apr 10, 2023

20

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

([email protected])

EMIF-AD– Pieter Jelle Visser

([email protected])– Mike Krams ([email protected])


www.emif.eu

Devices & Hardware

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