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Mats Sundgren, AstraZeneca
Coordinator
Potential of the use of electronic
patient information for clinical
research in the pharmaceutical
industry
The case of the EHR4CR project
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Outline
Problem statement
The EHR4CR project
Scaling up towards a pan-European platform supporting clinical research
Champion Program with Efpia companies
Governance via The European Institute for Innovation through Health Data
www.ehr4cr.eu
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PROBLEM STATEMENT
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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
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Improved access to health record data… …will speed up protocol design, patient recruitment, data capture &
safety reporting
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The burden of running a clinical trial has increased
Protocol design
Trials have become increasingly complicated
More endpoints to observe as science has expanded knowledge about how to measure safety and effectiveness
Patient recruitment
Larger on average and require more participants. Recruitment has become more difficult and expensive
Data capture and exchange
More data collected, more routine…
… more work
1999 2005 % Change
Unique Procedures per Trial (median)
24 35 46%
Total Procedures per Trial (median)
96 158 65%
Clinical trial Staff Work
Burden (measures in work-effort
units)
21 35 67%
Length of Clinical Trial (days) 460 780 70%
Clinical Trial Participant
Enrolment Rate
75% 59% -21%
Clinical Trial Participant
Retention Rate
69% 48% -30%
Source: PhRMA Report 2010
THE GROWING COMPLEXITY OF CLINICAL TRIALS
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THE PROJECT
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The EHR4CR project
EHR4CR – Electronic Health Records for Clinical Research
4+1 year project (2011-2016), 35 partners, budget >17M€
Objectives & Scope
Provide a 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 Champion Programme, connecting hospitals to an
operational platform, building up experience with pharma.
The European Institute for Innovation through Health Data – an
independent governance body.
For more information:
http://www.ehr4cr.eu/
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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).
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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
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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
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THE PLATFORM AND
SERVICES
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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!
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The EHR4CR platform – dataflow
Recruitment
Workbench
Central
Feasibility &
Recruitment
Workbench
ETL
Trial
Candidates
<< Queries
#Counts >>
#Counts >>
Enabled
<< Clinical Trial
Recruitment Progress >>
Recruitment Progress >>
EHR4CR PLATFORM HOSPITAL/DATA PROVIDER RESEARCH CENTRE e.g. pharmaceutical company
Protocol feasibility service
Patient recruitment service
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Evolution towards a mature platform service
EHR4CR proof of concept
Custodix commits to being an EHR4CR service & platform provider
Other know-how & experiences
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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
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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 )
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InSite central platform screenshot PFS viewing results
Country summary
Site summary
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SCALING UP: TOWARDS A
PAN-EUROPEAN PLATFORM
SUPPORTING CLINICAL
RESEARCH
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2015 – 2016 Champion Programme
“A multi-stakeholder collaboration
aiming to accelerate and ensure the
future of clinical research in Europe.”
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
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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.
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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
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THE GOVERNANCE
Governing the EHR4CR ecosystem
Educate and train Educate and train research and ICT staffresearch and ICT staff
Accredit staff Accredit staff and and organisationsorganisations
Certify service Certify service providers providers
and EHR systemsand EHR systems
Oversee and audit Oversee and audit governance & securitygovernance & security
EHR4CR
SERVICE PROVIDER
LOCAL PROVIDERS
SERVICE
USER PLATFORM
PROVIDER
SERVICE
USER
OTHER DATA
AGGREGATORS
DATA PROVIDER
RESEARCH
SPONSOR
RESEARCH
SPONSOR
DATA PROVIDER
ICT SOLUTION PROVIDERS RESEARCH
ORGANISATIONS
LOCAL
PROVIDERS
The needs…
… shared by multiple research projects
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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 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 the adoption of healthcare standards and of data quality, to enable more effective, safer and better integrated healthcare;
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.
Harmonised health information and Harmonised health information and standards standards
Harmonised health information and Harmonised health information and standards standards
Best practices in Best practices in information governanceinformation governance
Best practices in Best practices in information governanceinformation governance
Solutions for better quality health data, Solutions for better quality health data, and legitimate uses of dataand legitimate uses of data
Solutions for better quality health data, Solutions for better quality health data, and legitimate uses of dataand legitimate uses of data
Quality assessments, certification and Quality assessments, certification and auditaudit
Quality assessments, certification and Quality assessments, certification and auditaudit
Intelligence derived from health data e.g. Intelligence derived from health data e.g. research, outcomesresearch, outcomes
Intelligence derived from health data e.g. Intelligence derived from health data e.g. research, outcomesresearch, outcomes
Value Assessment programmesValue Assessment programmes Value Assessment programmesValue Assessment programmes
Clinical Research needs Healthcare needs
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Building synergy and consensus
i~HD will act as a focal point bringing stakeholders together to share
experiences, agree common priorities and approaches, working towards
convergence and cross-fertilisation between:
Patient associations
Citizen, family and carer associations
Health professional associations
Clinical and informatics academia
Healthcare providers
National decision makers
Third party payers, commissioners
EHR system and applications vendors
Medical Device vendors
Pharma, Bio-tech
Health data aggregators and consumers
Regulators
Standards development organisations (SDO)
Multi-national decision makers
Social care providers
Electronic health (eHealth) competence centers
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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
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CLOSER LOOK AT
CHAMPION PROGRAM
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Initial services
Protocol feasibility 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
“Protocol Feasibility services” cover a broader application domain than expected from the name. The service allows patient populations, hospitals and databases to be remotely and securely clinically assessed (distributed query). These services are invaluable for trial design, site selection, pharmaco-economics, etc.
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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
6 EFPIA Champion companies (Amgen, AZ, Bayer, Janssen, Roche, Sanofi) constitute the core Efpia Champions
Initiation autumn 2015
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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
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Summary
Hospital Champions
EFPIA Champion(s)
Partnerships
2015 2016 2017
Exiting times ahead!
First important steps from an European Private Public R&D project...towards an entirely
new collaboration model that have a potential to become a game changer in the clinical
research world…
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InterSystems & Custodix partnership
Central Platform
Query service
data
metadata
Aggregated
query results
Studies & queries
Reference terminologies
& terminology mapping
Pilot in Lille (FR)
• Accelerating InSite
installation through
integration with
HealthShare and
TrakCare
• Enriching data though
use of iKnow
