Swedish Science Council Stockholm

1. 1
Mats Sundgren, AstraZeneca
EHR4CR Coordinator
EHR4CR deployment plans in
Europe 2016 and beyond
Swedish Science Council, Stockholm
December 3, 2015

2. 22
Outline
 Problem statement
 The EHR4CR project
 Scaling up towards a pan-European platform supporting clinical
research
 Champion Program with Efpia companies and European hospitals
 Governance via The European Institute for Innovation through Health
Data

3. 3
PROBLEM STATEMENT

4. 44
There is a need to bridge the gap
We have imagined an environment where de-identified patient data
can be re-used within healthcare and research for clinical research
purposes…
 Across countries
 Across systems
 Across sites
…to speed up protocol
design, patient recruitment,
data capture, safety reporting…
Patient
health records
De-identified
data for Clinical
Research
as a beginning

5. 55
Problems with clinical trials
The percentage of studies
that complete enrolment
on time:
18% in Europe,
7%in the US1
Almost
50% of all trial
delays caused by patient
recruitment problems2
1/3of protocol
amendments are
avoidable, at a cost
of $0.5m
50%
of today’s clinical
trials fail to
achieve the target
recruitment4
Each day a drug is
delayed from market,
sponsors lose3 up to
$8m
3. Beasley, “Recruiting” 2008
4. Tufts -http://clinicalperformancepartners.com/wp-content/uploads/2012/07/Fixing-
Feasibility-Final-Jan-2012.pdf
1. State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics, Center Watch, 2008.
2. Study Participant Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia,
Business Insights, June 2007.
 Incomplete and delayed clinical trials are a sore spot of drug development

6. 6
THE PROJECT
6

7. 77
The EHR4CR project
 EHR4CR – Electronic Health Records for Clinical Research
 4+1 year project (2011-2016), 35 partners, budget >17M€
 Objectives & Scope
 Provide a scalable platform for trustworthy re-use of EHR data to
support innovation in clinical research and healthcare operations
 Unlocking Real World Data for optimising clinical trials
 Status
 Extended into 2016 for making the transition to a sustainable
platform
 Initiating a EHR4CR Champion Programme, connecting hospitals to
an operational platform, building up experience with pharma
 Established the European Institute for Innovation through Health
Data – an independent governance body
For more information:
http://www.ehr4cr.eu/

8. 88
The EHR4CR objective
 Research and develop a trustworthy service platform able to unlock clinical information stored in
EHRs for improving clinical research
 Clear focus on three (3) relevant use cases
SAFETY REPORTING
PROTOCOL
FEASIBILITY
PATIENT
RECRUITMENT
DATA
CAPTURE AND
EXCHANGE
Enabling protocol testing with
real world data in potential trial
sites rather than with
guestimates.
Speeding up recruitment by making
EHR data searchable for
investigators and establishing a
unified communication path
between sponsors and sites.
Facilitating EHR data extraction for
applications used during trial
execution (e.g. prefilling of CRFs
and of SAE reports).

9. 9
Brings together key stakeholders
35 participants
including
pharmaceutical
industry, academia ,
hospitals, SMEs, patient
associations and public
authorities
11 hospital
sites
10 Pharma
Companies
Advisory
boards and
other
experts

10. 1010
Status of the EHR4CR project…
EHR4CR - IMI
research project
Operational pan-
European platform
Pilot hospitals
 11 major hospitals in 5
countries.
 Germany (WWU, FAU)
 France (AP-HP, U936)
 UK (UoD, UoG, UoM, UCL, KCL)
 Switzerland (HUG)
 Poland (MuW)
Scaling up the
solutions!
 Technology
 Operations
 Governance
 Sustainability
Operational pan-European platform
 EHR4CR Champion Program
 Permanent network of clinical sites
giving access to millions of patients in
close to real time
 Trial design and recruitment supported
by real-world evidence on a European
scale
 Governance by the with European
Institute for Innovation through Health
Data
Project pilots
 Feasibility & Recruitment
 12 studies, different
therapeutic areas
 De-identified data from
>500k patients over 11 sites

11. 11
THE PLATFORM AND
SERVICES

12. 1212
The EHR4CR platform
Semantic
interop.
Security
AuthN
AuthZ
Audit
Workflow
Messaging
Platform
Management
Terminology
Services
Mapping
...Local
Applications
ETL
Site dependent
process
Application
Services
Centrally deployed
(Saas/Paas)
(Virtual)
appliance
NO patient
data leaves
the hospitals!

13. 1313
The EHR4CR platform – dataflow
Recruitment
Workbench
Central
Feasibility &
Recruitment
Workbench
ETL
Trial
Candidates
<< Queries
#Counts >>
#Counts >>
Enabled
<< Clinical Trial
Recruitment Progress >>
Recruitment Progress >>
EHR4CR PLATFORMHOSPITAL/DATA PROVIDER RESEARCH CENTRE
e.g. pharmaceutical company
Protocol feasibility service
Patient recruitment service

14. 1515
Protocol Feasibility workflow (study design)
Design study
(formalize
criteria)
Execute
(automated)
Central Platform
Clinical Site
9
2
5
Select sites of
interest
Launch queries
(test study)
Report
results
6
Analyze results
73 4
1
8

15. 1616
Patient identification & recruitment workflow
Formalize
the trial
criteria
Invite Sites
of interest
Accept study
participation
Fine tune
formalized
eligibility
criteria
Launch trial
at Site
Track
progress
Review
suggested
candidate
patients
After identification,
eligible patients
can be contacted.
If they consent to
the study, they can
be registered in
the trial through
the existing
processes.
Central Platform
Clinical Site
3
1
2 6 9
4 5 7
8

16. 1717
InSite Clinical Platform – overview
Patient Identification
and Recruitment
Service
Protocol Feasibility
Service
Site
Management
Central Platform
Cohort selection and
analysis tool
Computer assisted
patient recruitment
application
Site Services
Installed and used inside the hospital
Central service
available to
researchers

17. 1818
InSite central platform screenshot
PFS Authoring criteria (queries)
Clinical concept quick
search
Clinical concepts to
design queries with
(ICD, LOINC,
SNOMED, etc.)
Designing feasibility queries (i.e. eligibility criteria )

18. 1919
InSite central platform screenshot
PFS viewing results
Country summary
Site summary

19. 21
SCALING UP: TOWARDS A
PAN-EUROPEAN PLATFORM
SUPPORTING CLINICAL
RESEARCH
21

20. 2222
2015 – 2016 Champion Programme
The Champion Programme serves to:
 Further validate and improve technology
 Define (refine) the rules of engagement
for a sustainable ecosystem
 Start building a network of hospitals
 Engage with European Institute for
Innovation through Health Data which
aims to govern the EU data re-use
ecosystem
“A multi-stakeholder collaboration
aiming to accelerate and ensure the
future of clinical research in Europe.”
Targeting hospitals in
Belgium, Germany,
Finland, France,
Italy, Netherlands,
Poland, Spain,
Switzerland, Sweden,
and US

21. 2323
Better quality data
The clinical trial platform stimulates
hospitals to focus on the quality of
their data. Improved monitoring,
performance benchmarking,
reporting and management (e.g.
reimbursement coding) drives
optimization of patient care and
improved internal management.
Enhanced reputation
Hospitals and their physicians
participating in more clinical
trials will get greater visibility
in scientific community.
Which on its turn will attract
more research (trials), top-
class physicians and more
patients (once reputation gets
picked up by the media).
Better patient care
More patients will get access
to trial drugs and
innovative care pathways at
no additional cost to the
hospital.
Physicians participating in
clinical trial are in general
more up to date with medical
science.
Increased income
Cutting cost will no longer be
sufficient to deal with the
overall healthcare budget
decrease. Hospitals need to
search for new revenue
streams, the clinical trial
platform will help them to
attract more trials and thus
income.
Value for hospitals
Access to tools
Participation to the clinical trial
platform includes free access to
a set of tools to explore and
analyze patient data.
Anyone familiar with the cost of
clinical IT systems understands
the value of this benefit.
Value generated at multiple levels: clinical research, overall care provision and revenue

22. 2424
Value for pharma & research organisations
Clear value proposition for research organisations
Better trial design
 Optimising clinical protocol design will reduce costly
corrective measures such as protocol amendments, late
addition of new trial countries or sites.
Quicker achieved recruitment targets
 Computer assisted patient identification tools result in
accelerated identification, fewer patients missed,…
Increase revenue
 The platform will reduce the elapsed clinical trial time, which in the
end translates into a quicker time to market and thus additional
revenue (increased time on market under patent protection).
Reduce cost
 Less manual work, less corrective measures, etc. lead automatically
to a decrease in total trial cost. Pharma will also avoid the expense
and time and effort of opening trial sites which will not yield enough
patients.
Overall increased efficiency
 Further automation and optimisation of the clinical trial
process by use of a central platform result in an overall
increased efficiency.
Improve trial success rate
 The number of trials failed due to failure to recruit will be
reduced.

23. 25
THE GOVERNANCE

24. 26 2
6
The European Institute for Innovation through Health Data (i~HD)
has been formed as one of the key sustainable entities arising from the EHR4CR and
SemanticHealthNet projects, in collaboration with several other European projects and initiatives
supported by the European Commission
i~HD is registered in Belgium
as a not-for-profit organisation
It is being financed by membership fees,
by providing services
such as certification and governance and through
specifically-funded projects and initiatives
Guiding and catalysing the best, most efficient and trustworthy
uses of health data and interoperability,
for optimising health and knowledge discovery
www.i-hd.eu

25. 27
i~HD has been formed because a complementary, neutral and
not-for-profit organisation is needed
 to play a central role in governing and expanding a trustworthy health
data driven ecosystem including EHRs and EHR4CR platform services
 to promote the adoption of healthcare standards and of data
quality, to enable more effective, safer and better integrated healthcare
 to act as a connector between health care and clinical research
standards, that are presently developed in silos and impair the
interoperability and pooling of health data for research
 to promote to society the importance of using health data for
research, to improve efficiency through reduced duplications, delays,
costs enhance speed and efficiency in clinical studies

26. 30
i~HD will
 provide an essential governance framework for the scale up of EHR4CR and
future research platforms across Europe
 certifying research platforms and service providers
 establishing codes of practice and privacy protection policies
 conducting audits and investigating any concerns about security and privacy
 educating the public of the value of using health data for research and
assuring them about the governance protecting their privacy
 support better quality and interoperability of health data
 establishing a Network of Excellence amongst data providers to improve data quality
 identifying ICT mature data sources e.g. hospitals
 facilitating alignment amongst standards bodies, especially in semantic interoperability,
ensuring that future standards prioritise clinical and research needs
3
0

27. 31
CLOSER LOOK AT
CHAMPION PROGRAM

28. 3232
Long term objective
 Establish a network of clinical sites able to quickly engage into clinical research
 Connect clinical sites to the clinical platform bringing them in close contact with EFPIA
companies and CROs
 Empower clinical sites to support clinical trial processes through locally provided technology
 Computer assisted recruitment, extraction of EHR-data for reporting (eCRF, SAE, …), cohort analysis,
etc.
 Provide a multitude of services to optimise internal clinical trial processes through data
re-use, freeing up time for care & research
 Protocol feasibility, patient recruitment, EHR data extraction, eCRF and report pre-filling, etc.

29. 3333
Initial services
Protocol feasibility / Trial
Design services
 Optimise protocol eligibility
criteria by instantaneously
testing them out in multiple sites
in various countries
 Directly identify the countries
and specific sites to approach
for participation
Trial recruitment services
• Distribute trial protocols over
multiple sites in a uniform way
• Track recruitment progress in
real time
• Optimal recruitment due to
tools provided to hospitals
Starting with a simple
service offering for
Research Organisations
 Initial focus is on building the
network and introducing the
technology in hospitals
 The two services should be able
to demonstrate the value of this
initiative to all stakeholders
 Piloting new services will be
done as the need arises
 The service offering will be
expanding as the technology
matures

30. 3434
Efpia Champion Programme summary
The Champion Programme is designed to provide a low-risk entry for all stakeholders into this innovative approach to efficient use of
Real World Data. It is a key step in building the EHR4CR envisaged ecosystem of network of hospitals, service providers and pharma
users.
 Objectives
 Validating and further improving the platform together with Custodix (first Service and Platform Provider) by connecting 15-30
hospitals during 2015-2016.
 Define (refine) the rules of engagement for a sustainable ecosystem (including defining the governance role of the European
Institute of Innovation in Health Data).
 Scope
 Evaluate platform services for Protocol Feasibility, Patient Identification & Recruitment across multiple therapeutic areas (TAs)
with a broad geographical coverage in Europe and reaching out to the US.
 Outcome
 A proven ecosystem for acceleration of clinical research through Real World Data, ready to further expand geographically
and data source wise (registries, research data bases, PHR, mHealth apps data, …)
 Status
 7 EFPIA Champion companies (Amgen, AZ, Bayer, GSK, Janssen, Roche, Sanofi) constitute the core Efpia Champions
 Initiation autumn 2015

31. 3535

32. 36
CLOSER LOOK AT
CONNECTING HOSPITALS

33. 3737
4-stage Site Intake Process
Champion Hospital intake process
 Stage 1: expression of interest
 Introduction to Champion Programme
principles
 Stage 2: site assessment
 Site readiness assessed by Custodix
 Technical readiness & data availability
 Stage 3: planning and agreement
 Entering into a formal agreement
 Stage 4: implementation
 Preparing the site for connection to the
platform
CONFIDENTIAL
NDA
Clinical Partner Agreement
Agreement
signoff

34. 3838
Intake Process
CONFIDENTIAL
Installation
checklist
ETL
Preparation
Node
Preparation
Connectivity
Test
Iterative ETL
process,
trouble-
shooting and
fine-tuning
validation
through
the InSite
query
system
Assessment
Design &
Explorative
test
IT Integration (software, networking, etc.)
Data Integration (semantics)
Planning

35. 3939
Data of Interest
CONFIDENTIAL
 Data of Interest
 Demographics, diagnosis, procedures, medication,
laboratory
 Local terminology/vocabulary is mapped to reference
terminologies
 Clinical findings
 Fixed list of clinical concepts
 Base list originates from the EHR4CR project, will be further
curated
 “Catch-it-all” and Incremental Mapping approach
 Whatever is easily available
 Whatever was needed for a specific project

36. 4040
Data of Interest
CONFIDENTIAL
Category Reference
terminology
used
Remarks
Demographics SNOMED-CT SNOMED-CT concepts for age and gender.
Clinical Findings SNOMED-CT Fixed list of clinical concepts.
Originates from EHR4CR project, selection of top concepts found in clinical trials
and expected to be available at hospitals.
Will be curated and will evolve during Champion Programme.
If possible “opportunistic catch-it-all” .
Diagnosis ICD-10-CM Mapping to ICD-9-CM included in the reference installation.
Procedures ICD-10-PCS Mapping to ICD-9-CM included in the reference installation.
Medication ATC Full 7-character code without DDD indication.
Lab LOINC Relevant subset of LOINC (e.g. excluding orders and panels).

37. 4141
Stage 4: deployment
Data Integration Process
CONFIDENTIAL
Site Assessment
• Overall
assessment of
“site readiness”
• Determine the
effort required
for connecting
to InSite
Data source
“deep” analysis
• Detailed
analysis of
selected data
sources:
• Syntax
• Semantics
• Data content
• Data access
ETL design
• Design ETL
mapping to
Clinical Data
Warehouse
data model
using templated
Terminology
Mapping Strategy
• Determine
terminology
conversion
strategies
Deployment
• Implement data
extraction
• Configure InSite
Node TL-
pipeline
 Iterative (cooperative) process
Stage 2 Stage 3: planning and agreement

38. 4242
Integration Example
CONFIDENTIAL
 Integration based on existing
reports (data exports)
 Lab using local coding system
 LOINC conversion provided
for top concepts
 Full LOINC conversion
planned

39. 4343
CDW
Integration Example
CONFIDENTIAL
data
metadata
 Tight integration with the EHR
 TrakCare / HealthShare product of
InterSystems
 Generic TrackCare – InSite connector built
 Real time data
 Re-useable for other TrackCare instances
 Local terminologies mapped as needed

40. 44
Thank You! Contact us:
comms@ehr4cr.eu
European Institute for Innovation
Through Health Data
www.i-hd.eu
Custodix InSite Platform
www.insiteplatform.com

41. 4545
The EHR4CR project is an important initiative
 Bringing together multiple
stakeholders
 Overcoming barriers that limit
access to EHRs for research
 Developing a platform and
services for trustworthy re-use of
EHR data within and outside
Europe
Patient
health records
Clinical
researcher
De-identified
data for
Clinical
Research
www.insiteplatform.com