ADVANCING MEDICAL
RESEARCH THROUGH
HEALTH INFORMATION
TECHNOLOGY
Stakeholder Awareness Session
Wednesday, 20 November 2013
WELCOME AND
INTRODUCTION
Mats Sundgren,
Astrazeneca &
Agenda
Session
Speaker (s)
Welcome and Introduction
Mats Sundgren, AstraZeneca and Sebastian Semler, TMF
Context of the Project
Richard Perkins, eClinical Forum
Project Highlights
Dipak Kalra, University College London
Exhibition: Walking the Booths
Introduced by Andreas Schmidt, F-Hoffman La Roche
Value Propositions and Sustainability
Danielle Dupont, Data Mining International
Wrap-up and Outlook
Georges De Moor, EuroRec
Objectives
Demonstrate the need to create a new model for clinical research
to transform development of and access to innovative medicines
for patients – in full compliance with all relevant ethical, legal and
privacy protection standards and policies
Outline new business model that leverages advances in health
information technologies
Demonstrate technical and commercial opportunity within this new
What is EHR4CR?
Mandated by IMI
One of the largest European public/private partnership
projects in this area
4-year project (2011-2015)
Budget of € >16m
For further information
see www.ehr4cr.eu or
contact
Geert Thienpont
(EuroRec)
EHR4CR Executive Committee
Mats
Sundgren
Andreas
Schmidt
Dipak
Kalra
Georges
De Moor
Brecht Claerhout
&
Louis Schilders
Nadir
Ammour
Martin
Dugas
Christian
Ohmann
Florence
Botteri
What is the IMI?
A unique public-private programme co-funded by the European
Commission and the European Federation of Pharmaceutical
Industries and Associations (EFPIA)
A pan-European collaboration that brings together large
biopharmaceutical companies, patient organisations, academia,
hospitals, small- and medium-sized enterprises (SMEs) and public
authorities
CONTEXT OF
THE PROJECT
Richard Perkins,
eClinicial Forum
A NEW BUSINESS
OPPORTUNITY IN A
NUTSHELL
Growing need to speed up the development of
innovative drugs
1. http://www.unfpa.org/webdav/site/global/shared/documents/publications/2012/UNFPA-Exec-Summary.pdfAgeing
Population
1 in 9 ≥ 60
1 in 5 by 2050
1 CV Diabetes COPD Asthma HIV/ AIDS By 2030, 10% of European adults are predicted to have diabetes, compared with 8.5% in 20102 Advent of personalised medicine/targeted therapies Long-term chronic disease management A NEW BUSINESS OPPORTUNITY IN A NUTSHELL3. Bray F, Jemal A, Grey N, et al. Global cancer transitions according to the Human Development Index
Number of people with dementia will nearly double every year4
Mental disorders Cancer 0 50 100 150 2010 2020 2030 2040 2050 N u m b er o f p eo p le (m ill io n s) By 2030, 22.2m new cases of cancer are expected to be
diagnosed annually3 0 10 20 30 2008 2030 N u m b er o f p eo p le (m ill io n s)
Drug innovation is slowing down
Escalating R&D costs & increasing obstacles to clinical research
1. iHealth Connections, EHR4CR case study; 2. IFPMA. 2011 statistics; 3. EFPIA, The Pharmaceutical Industry in Figures. Key Data 2009. Update. 1–27; 4. OECD.http://www.oecd.org/els/health-systems/HealthAtAGlanceEurope2012.pdf. Last accessed October 2013.
0 5000 10000 15000 20000 25000 30000 35000 40000 1990 2000 2011
Europe €m
USA $m
Japan ¥m x100
R&D Expenditure Escalating R&D costs reflect increasing technical and regulatory challenges facing pipeline Globally, pharma industry alone spends $135 billion
on R&D per year2,
yet only 2-5% of projects hit market Lengthy clinical
development processes - 8-10
years1
Shift in research sites from Europe to
Asia3 Public health expenditure is rising, accounting for an average 9% of GDP in 2010, compared with 7.3% in 2000.4 A NEW BUSINESS OPPORTUNITY IN A NUTSHELL
The advent of personalised medicine is
increasing the need for patient data
Personalised medicine is tailored to the
individual, meaning more effective drugs with
fewer side effects
Requires selecting patients by specific
genotypes
Relies on recruiting highly selected patient
groups
Requires more patient data from health
records
In current framework, personalised medicine
difficult to accommodate in clinical trials
We are no longer trying to produce drug
products that treat the majority of the
population of the planet. This means we
need to target and understand the right
patients. To test if our inclusion/
exclusion criteria make sense, we need
to have much more external health
information and patient data.
Mats Sundgren,
Global Clinical Development,
AstraZeneca
A NEW BUSINESS OPPORTUNITY IN A NUTSHELL“
”
There is a solution…
Transform current clinical
research models to help bring
innovative medicines to market
faster and at a lower cost
Enhance efficiency and
success rate of clinical
research – i.e. speed it up and
make it more efficient
Create a uniform system of
research and information
exchange by reusing existing
longitudinal patient level data
available in electronic health
records (EHRs)
SLOW
LANE
FAST
LANE
A NEW BUSINESS OPPORTUNITY IN A NUTSHELL…that benefits all sponsors of clinical research,
including the pharma industry
Research and develop new drugs
Demonstrate safety & efficacy to satisfy
regulatory requirements
Evaluate the ‘real-world’ comparative
effectiveness, safety and
cost-effectiveness of innovative medicines
compared to existing therapies
Improve health outcomes
The pharmaceutical
industry started over
3,500
new clinical
trials in 2012
158%
to enable
licensing of an
innovative drug
1 A NEW BUSINESS OPPORTUNITY IN A NUTSHELL…and academia, government agencies, non-profit
organisations
Criteria for diagnosis, disease progression and intervention The health system at largeThe role of genes in health/disease development A NEW BUSINESS OPPORTUNITY N A NUTSHELL The role of patient education
CURRENT
CHALLENGES IN
CLINICAL
Clinical research is costly, long, complex
Source: EFPIA. The Pharmaceutical Industry in Figures. 2013
3.5 21.5 8.3 9.8 8.7 12.5 35.7
Pre-human/Pre-clinical
Phase I
Phase II
Phase III
Approval
Pharmacovigilance (Phase IV)
Uncategorized
Clinical trials
CURRENT CHALLENGES IN CLINICAL RESEARCHAllocation of R&D investments by R&D phase (by %)
The clinical trials process is long
CURRENT CHALLENGES INCLINICAL RESEARCH
PHASE I
20-100 Volunteers 100-500 PatientsPHASE II PHASE III
1,000-5,000 Patients
F
R
OM
PR
E
-C
L
IN
IC
A
L
D
EVEL
OPM
EN
T
5 c om po un ds 1 c o mp o u n dTO
M
A
RK
ETI
NG
A
UT
HOR
IS
A
TIO
N
CLINICAL TRIALS
Determine
safety and
dosage
Evaluate effectiveness and side effectsValidate effectiveness and safety in long term use
*Mean clinical development time for therapeutic NMEs approved 2005-2011 (Source: Tufts CSDD) 6.8
Clinical trial complexity has increased
As science has expanded
knowledge about how to measure
safety and effectiveness, trials
have become increasingly
complicated
More endpoints to observe
Larger on average and require
more participants
Recruitment has become more
difficult and expensive
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
CURRENT CHALLENGES IN
CLINICAL RESEARCH
Protocol design based on estimates
Protocols governed by
established standards
With no, or limited
access to actual patient
data, trial design is
based on discussions
with expert clinicians
Increased amendments,
slower than expected
enrolment, costly
changes to add new
sites and countries,
even failed trials
A third of
protocol
amendments are
avoidable
1, at a
cost of $0.5m
per amendment.
2 CURRENT CHALLENGES IN CLINICAL RESEARCHHow long will the trial take?
Will we be able to recruit the necessary volume of patients in order to collect data with sufficient statistical
power to meet regulatory requirements?
Where will we find sufficient numbers of
the right patients? Do the
inclusion/exclusion criteria make sense?
1. Drug Information Journal, Vol 45, 2011 2. Industry Standard Research, 2010
Patient recruitment a major
cause of trial delays
With no searchable patient database, identifying and recruiting suitable patients and trial
sites are principal causes of trial delays
Delayed trials waste costly resources and slow access to new drugs
50%
of today’s clinical trials fail to achieve the
target recruitment rate4
Almost
half
of all trial delays caused by patient recruitment problems21. 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. 3. Beasley, “Recruiting” 2008
4. Tufts -http://clinicalperformancepartners.com/wp-content/uploads/2012/07/Fixing-Feasibility-Final-Jan-2012.pdf
Each day a drug is delayed from market, sponsors lose up to
$8m
3
The percentage of studies that complete enrolment on time:
18%
in Europe,7%
in the US1 CURRENT CHALLENGES IN CLINICAL RESEARCHPatient care (health records) &
clinical research divided
No easy access to EHR on population basis (only via individual hospitals)
Patient data
Clinical data
(e.g. EDC)
Manual re-input
of patient data
CURRENT CHALLENGES IN CLINICAL RESEARCHRedundant data entry
Clinical trial data are
manually
entered
into dedicated electronic clinical trial
systems (EDC) and the same
information is often also entered into
EHR systems
Cumbersome and slow processes
Transcription inconsistencies
1. Integrating Electronic Health Records and Clinical Trials: An Examination of Pragmatic Issues, Michael Kahn, University of Colorado.
2. EDC Site Survey: Investigational Site Perspectives on Clinical Trial Information Systems, eClinical Forum 2009. Available at: www.eclinicalforum.org (accessed December 1, 2011).
40%
of clinical trial data are entered into the patient’s health record, the clinical trial EDC system, and, possibly, a third paper copy1
Over
70%
of data are duplicated between EHR and clinical trial systems2
Investigational sites estimate that over
CURRENT CHALLENGES IN
CLINICAL RESEARCH
There is a need for re-use of electronic health
records
Access to patient data is key to
bottlenecks in clinical research
Prior, during and after clinical trial
E.g. to identify suitable patients for trials, monitor
adverse events, evaluate treatment outcomes
Fundamental problem is how to access share
electronic patient health records
Disparate and separate systems
Patient care, laboratory, pharmacy, etc.
Different purpose
Patient care and/or provider reimbursement
Multiple formats
Narrative, images (X-rages), recorded data
from instruments (e.g. ECG), genetic sequence data, etc.
CURRENT CHALLENGES IN CLINICAL RESEARCH
Improve
efficiency
Manage
complexity
Improve
adverse
event
reporting
Make new
medicines
available
faster
USING
ELECTRONIC
HEALTH RECORDS
TO REMOVE
EHR use has expanded rapidly
Rapid expansion over past 5-10 years
EHR is now routinely used in clinical care
In some countries nearly 90% of all healthcare
records are digital
Some informatics companies are focused
on integrating large data platforms
Some companies specialise in
aggregation of large datasets
USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKS
Re-use of electronic health records is possible
Recent developments in EHRs provide
the opportunity to mine the data they
contain for use in clinical research
Technology has progressed to the point
that EHRs can be seamlessly integrated
with existing research platforms and
healthcare networks
We can already imagine an environment
where de-identified patient data can be
shared electronically between healthcare
and research
USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKSRoutine health
data (EHR)
We can imagine an interoperable ideal
EHRs seamlessly integrated with existing
research platforms and healthcare networks
Research systems and healthcare systems
sit on the same spine
Connect and re-use EHR information on a
large and scalable way – across
organisations, regions and countries
Allows integration of lifecycle of clinical
studies with heterogeneous clinical systems
Data access and mining capabilities
Systems conform to the same data
exchange standards
USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKS Clinical researcher Patient Clinical trialAccess to health records speeds up protocol design,
patient recruitment, data capture & exchange
Evaluate patient populations in study set up
Query EHR database to establish number of potential candidates
Improve and validate study designs
Accelerate patient identification and recruitment
Query EHR database to select sites and identify and recruit patients
Implement study screening parameters into patient registration and scheduling
Researchers obtain key health information before patients arrive for a screening visit (after consent)
0010100101 100101001 01 110 01001010010 1100010101110100 1001 010011 01100101001 010101101010101 10 00101011101100 1011111100 100101 P A T IEN T S PR OT EC T ED B Y L EGA L A N D PR IV A C Y PR OT EC T ION ST A N D A R D S & R EGU L A T ION S USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKS
Capture clinical trial data
Incorporate study-specific data capture as part of routine clinical care
Auto-populate study data elements into case report forms from other parts of EHR database
Minimise duplication of data collection Exchange clinical trial data
Facilitate Serious Adverse Event reporting
Efficient patient data collection for study conduct
EHR becomes patient
data repository to
streamline clinical
trials
A new type of clinical trial with EHR
Smaller, more data rich trials with
exactly the right patients
Innovative research in real-life settings
e.g. comparative effectiveness,
observational studies, health economics
assessments
Closer collaboration between hospitals
and researchers
USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKSRoutine health
data (EHR)
Clinical trial research
data (Electronic Data
Access to patient data is key to bottlenecks in clinical
research
Optimise clinical protocol design (reduce
amendments)
Accelerate and improve accuracy of patient
identification and recruitment (identify patients
missed today, achieve recruitment targets)
Eliminate non-value added tasks (reduce
redundant data entry)
Improve quality of data (fewer transcription errors)
Improve Adverse Event reporting (real-time safety
monitoring and reporting)
1. Beasley, “Recruiting” 2008 DEVELOPMENT TIMES COSTS SAFETY REPORTING USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKS
Win for all stakeholders
Pharma, academia, CROs
Clinical trial development will become more efficient by reducing the time it
takes to bring new drugs to market, thus generating substantial
value
Hospitals
Able to participate in more clinical research
programmes, benefiting their
patients
Health authorities
Access to new and better evidence to
underpin health policy, strategy and
resource planning
Health community/ governments
Able to offer improved quality of healthcare
with reduced healthcare costs
EU
More attractive for R&D investment
Patients
Faster access to safe and effective medicines, improving health outcomes across Europe USING ELECTRONIC HEALTH RECORDS TO REMOVE BOTTLENECKS
PROJECT
HIGHLIGHTS
Dipak Kalra,
MAKING
INTEGRATED EHR
FOR CR A REALITY
Interoperability
EHRs generated by single institutions (the doctor has a set of information for each patient; if the patient goes to another doctor there is another set of information)
Separate and disparate systems
Incompatible EHR systems
Different models
Quality, uniformity and organisation of the data is extremely variable, making it difficult to integrate and use
Different languages across Europe
Ethical, privacy &
legal issues
Secondary use of patient EHR data for clinical research
How to protect patient privacy
How to secure consent
Integrity &
trustworthiness of data
Need assurance within EHR systems of security, with confidentiality, integrity and general trustworthiness to meet requirements for high-quality clinical research data (Good Clinical Practice)
What are the current barriers to
using EHR for CR?
MAKING INTEGRATED EHR FOR CR A
Key challenges to overcome in integrating
EHR and CR
Complying with ethical,
legal and privacy
requirements that differ
from country to country
is critical
to gainacceptance with the general public, patients, and medical professionals
Provide a platform that
enables access to many,
different EHR systems
different types of data needto be integrated (protocol eligibility criteria, clinical research data items and EHR data) to enable distributed queries across multiple patient-centred sources to support cohort identification
Ensuring the
correctness,
completeness and
accuracy of the data
(quality assurance)
Sustainability within a
scalable business
model
MAKING INTEGRATED EHR FOR CR A REALITYEthical, privacy and legal challenges
Use of patients’ medical information for secondary
purposes
Patients need to know data is held securely and
privacy ensured
Must be trustworthy and transparent
Laws and regulations differ for processing personal
data in different countries
Additional laws regarding medical research
EU Data Protection Directive 95/46/EC
The upcoming EU Data Protection Regulation (2014)
MAKING INTEGRATED EHR FOR CR A
This is where EHR4CR comes in
Design and demonstrate a sustainable and cost-effective
approach to inter-operability, in full compliance with ethical,
regulatory and data protection policies and requirements
Provide adaptable, reusable and scalable solutions (tools and
services) for re-using data from Electronic Health Record systems
for Clinical Research
MAKING INTEGRATED EHR FOR CR A
What is the role of the EHR4CR?
Engagement and specification of requirements Develop Sustainable Business Model Technical Platform to demonstrate value of services (a set of tools and services) Governance structure for trustworthy reuse of EHR for CR Pilots for validating the solutionsCatalyst for scalable and sustainable re-use of EHR data for CR
MAKING INTEGRATED EHR FOR CR A
Requirements informed by stakeholders
95% in favour of reuse of EHR data (internal
& external stakeholders)
Identified issues that need to be addressed
Priority services: protocol feasibility, patient
identification and recruitment, exchanging
data with EHRs for clinical trial data
collection, adverse event reporting
Interviews with stakeholders helped inform
software requirements (Protocol Feasibility
Service and Patient Identification and
Recruitment Service)
203 respondents from
23 EU countries
Pharma, academia, CROs,
Patient advocacy groups,
Health agencies, IT providers
EU survey
95%
rated compliance with
ethical, legal and
privacy requirement
s
as the highest, or equal
highest driving force
for success of
EHR4CR
1 MAKING INTEGRATED EHR FOR CR A REALITY1. Kalra D, Schmidt A, Potts HWW, Dupont D, Sundgren M, De Moor G, on behalf of the EHR4CR Research consortium. Case Report from the EHR4CR Project: A European Survey on Electronic Health Records Systems for Clinical Research. iHealth Connections 2011; 1(2): 108-113.
Survey informed aspects of clinical trials
in most need of improvement
Identifying patients for participation in clinical
trials
Optimizing the time currently required to conduct clinical trials
Reducing the costs of conducting clinical trials
Reducing the workload of conducting clinical trials
Evaluating protocol feasibility 0% 10% 20% 30% 40% 50% 60% 70% 80%
Aspects of clinical trials in most need of improvement
MAKING INTEGRATED EHR FOR CR A
Ensuring privacy protection
Protecting patient privacy and complying with European,
national and hospital specific privacy protection rules is crucial
Examined European and national legislation for all EHR4CR
pilot sites
Consultation workshops and surveys of key stakeholders and
decision makers about EHR4CR services
Confirmed legitimacy and strong support for EHR4CR design
approach (e.g., by patient associations and data protection
officers)
Data security and privacy protection guidelines are made
available to support/improve the EHR4CR integration with
different EHRs
MAKING INTEGRATED EHR FOR CR A
Our key design principles
Analyse de-identified health records at participating hospital sites
Platform only connected to dedicated repository approved by each
hospital for EHR4CR use
For protocol feasibility and patient identification/recruitment, only
patient counts (totals and sub-totals) are returned from each
hospital to the central EHR4CR Platform, never patient level data
Platform never stores or communicates data about single data subjects
Data about individuals, who might be invited into a study, remain
internal to the hospital and abide by its local governance rules
Only treating physicians can re-identify candidate patients
EHR data is only shared - within the hospital - with a clinical
research team if the patient has given that specific consent
MAKING INTEGRATED EHR FOR CR A
Ensuring robust governance
Only approved users are formally registered and given
secure log in credentials
Users have no means of requesting or obtaining patient
level data through the services
Even patient numbers are suppressed if the numbers are
very low
State of the art information security measures are used
throughout
Audit logs are captured at key communications points:
Pharma sites, within the Platform and at hospitals
A Code of Practice and Standard Operating Rules will
govern the actions of all parties using the EHR4CR
services
MAKING INTEGRATED EHR FOR CR A
Technical Platform - requirements
Technical Platform (a set of tools and services)
Support the feasibility, exploration, design and execution of
clinical studies and long-term surveillance of patient populations
Enable searches for relevant patients across distributed EHR systems
Initiate confidentiality participation requests via the patients’ authorised
clinicians
Harmonised access to multiple heterogeneous and distributed
EHR systems
Integration with existing clinical trials infrastructure products
(e.g. EDC systems)
Facilitate improvements of data quality
Enable routine clinical data to contribute to clinical trials and vice versa
Reduce redundant data capture
MAKING INTEGRATED EHR FOR CR A
Technical Platform: what has been
achieved so far?
Protocol Feasibility Service
Architecture description (blue print) and technical specifications
A formal and validated Software Requirements Specification
Contains approx. 75 use cases, over 200 requirements
First version of EHR4CR platform developed - Service
Orientated Architecture (SOA)
E.g. service registry, security infrastructure, services
Platform reference implementation
Evolving information model (common language)
Based on generic reference models (e.g. ISO/HL7 RIM and
CDISC/HL7 BRIDG)
MAKING INTEGRATED EHR FOR CR A
Technical Platform: progressing further services
Patient Identification and Recruitment Service
Software Requirement Specification defined and agreed
Technical specification defined and agreed
New iteration of platform infrastructure services (e.g. message oriented
middleware, security services, terminology services,
On-going application development
Demo system is available
MAKING INTEGRATED EHR FOR CR A
Validated solutions
Developed different pilots for validating the solutions:
For different scenarios (e.g. protocol feasibility)
Across different therapeutic areas (oncology, inflammatory diseases,
neuroscience, diabetes, cardiovascular diseases, respiratory diseases)
Across several countries (under different legal frameworks)
De-identified EHR data from EHR4CR hospital partner sites
Validate the platform and proof-of-concept services
Shape a sustainable business model
MAKING INTEGRATED EHR FOR CR A
Results of Protocol Feasibility Service pilot
Tested viability and performance of
EHR4CR platform to support protocol
feasibility service
o
11 hospitals in five countries
o
EHR4CR-compliant data warehouses were
established at all pilot sites
o
Large set of eligibility criteria from EFPIA
trials analysed to identify commonly used
data
elements (82 EHR data elements)
o
Data for these elements was loaded into
local EHR4CR-compliant data warehouses
as far as available at the sites
o
12 clinical studies evaluated, technical
testing of four clinical studies
Germany (WWU, FAU)
France (AP-HP, U936)
UK (UoD, UoG, UoM, UCL, KCL)
Switzerland (HUG) Poland (MuW) MAKING INTEGRATED EHR FOR CR A REALITY
Protocol feasibility proof-of-concept
A subset of the previously selected 12 studies were used for the two
proof-of-concepts (POC)
Initial POC (October 2012): four studies, with 34 steps
Extended POC (January 2013): ten studies, 105 steps for application testing
User Acceptance Test (UAT) protocols: two documents for the
assessment of the feasibility testing
First document: consisting of a high level definition of a ‘successful’ outcome of
the feasibility testing
Second document: a detailed, step-by-step guide for the various functions to be
tested during the functionality testing for protocol feasibility
MAKING INTEGRATED EHR FOR CR A
Protocol Feasibility Service Pilot
– end user view of the application
MAKING INTEGRATED EHR FOR CR A
PFS proof-of-concept outcome
Conclusion of defined POC success criteria:
Retrieving information from hospital sites:
Timely response but endpoints without data halt query execution
Reliability of information returned: to be tested (next round)
Query modification and re-running of queries:
Transnational platform across systems and hospitals:
MAKING INTEGRATED EHR FOR CR A
REALITY
Fulfilled 80% of all assessment
criteria
Pilots: Next steps
Assess the next three scenarios
Patient identification – ongoing
Trial execution – 2014
Serious adverse events reporting – 2014
MAKING INTEGRATED EHR FOR CR A
EXHIBITION: WALKING
THE BOOTHS
Andreas Schmidt,
F-Hoffman La Roche
VALUE PROPOSITIONS
AND SUSTAINABILITY
Danielle Dupont,
A SCALABLE
SUSTAINABLE
ECOSYSTEM
Establishing an integrated EHR4CR ecosystem
Demonstrating the viability of a sustainable business model is a crucial first step to success
A sustainable EHR4CR business model must include various elements to connect providers
and receivers of EHR data through different services (e.g. patient recruitment)
Is it scalable?
How will it be
financed?
How can we
guarantee the
integrity of data and
service providers?
A SCALABLE SUSTAINABLE
Stakeholders in the new ecosystem
An organisation that uses EHR4CR services such as a pharmaceutical company or an academic institution Service Provider – an organisation that provides EHR4CR services to Service Users Network Provider – an organisation that provides dataaggregation and access services to Service Providers through standard EHR4CR interfaces An organisation that contributes data for EHR4CR
e.g. hospital Application Providers – software applications offered by Service Providers, that provide EHR4CR services. Service providers may develop these themselves or use Third Party
Suppliers Service User Technical service providers Data Provider A SCALABLE SUSTAINABLE ECOSYSTEM
EHR4CR ecosystem overview
SERVICE PROVIDER APPLICATION PROVIDERS APPLICATION PROVIDERS SERVICEUSER SERVICE USER
1 SERVICE PROVIDER APPLICATION PROVIDERS APPLICATION PROVIDERS SERVICE
USER SERVICE USER
2 SERVICE USER SERVICE PROVIDER APPLICATION PROVIDERS APPLICATION PROVIDERS SERVICE
USER SERVICE USER
3 SERVICE PROVIDER APPLICATION PROVIDERS APPLICATION PROVIDERS SERVICE
USER SERVICE USER
4
DATA PROVIDER A DATA PROVIDER B DATA PROVIDER C
NETWORK PROVIDER NETWORK PROVIDER INTERCONNECT INTERCONNECT EHR4CR INSTITUTE
UK DATA ONCOLOGY DATA
PROTOCOL DESIGN & FEASIBILITY A SCALABLE SUSTAINABLE ECOSYSTEM
Seeding the ecosystem
SERVICE PROVIDER APPLICATION PROVIDERS APPLICATION PROVIDERS SERVICE USER SERVICE USERDATA PROVIDER A DATA PROVIDER B
EHR4CR INSTITUTE
A SCALABLE SUSTAINABLE
What would a thriving ecosystem look like?
Free market in interoperable EHR4CR software components,
services and solutions
A growing number of application providers, service providers, data
providers
Framework to ensure trustworthy re-use of data
Demonstrable value to ecosystem players (e.g. faster patient
access to new safe and effective drugs)
A SCALABLE SUSTAINABLE
Accreditation and certification are key
Ensures reliability and trustworthiness of the data providers,
service providers and data users
Accelerates adoption of harmonised approach throughout Europe
A SCALABLE SUSTAINABLE
Role of EHR4CR Institute
Critical to the sustainability of EHR4CR
Provides environment for EHR4CR
ecosystem to develop
Not-for-profit, formally registered
company providing services to
registered members (e.g. data
providers, data users, service
providers)
Funded by license fee, subscriptions,
certification, membership (cover cost
of operations and providing services to
registered members)
Profits reinvested to improve services
& fund public interest research
EHR4CR
Institute
Specifications and standards Promotion of EHR4CR services Accreditation and Certification Oversight, governance, auditing Build EHR4CR community and best practices Guardian of shared Intellectual Property A SCALABLE SUSTAINABLE ECOSYSTEMEHR4CR Economic Analyses
EHR4CR Cost-Benefit Assessment (CBA)
To establish the value of EHR4CR services to pharmaceutical
industry
Perspective of the primary payers
Assesses and compares EHR4CR conditions to current practices
Central to the EHR4CR value proposition
EHR4CR Business Model Simulation
To forecast the business results from a EHR4CR service
provider perspective
Estimated expenses and revenues
Results expressed as:
Balance sheets (revenues minus expenses)
Profitability ratio (revenues divided by expenses)
A SCALABLE SUSTAINABLE
EHR4CR Cost-Benefit Assessment
Objective
To assess and compare the value of EHR4CR services versus current practices
Perspective
Pharmaceutical industry
Therapeutic
Area
Oncology (Phase II-IV trials)
State-of-the-Art Approach
Multidisciplinary expert panel Health economists
Pharmaceutical industry
Academia
Advanced and robust simulation modelling
Results
Actual R&D man-time saved with EHR4CR services
Efficiency gains expressed as:
Absolute cost-benefit (cost minus benefits)
Relative cost-benefit (cost/benefits)
A SCALABLE SUSTAINABLE
ECOSYSTEM
BENEFITS
COSTS
EHR4CR CBA
Preliminary Findings
The EHR4CR CBA preliminary findings suggest that:
Compared to current practices, EHR4CR services appear more efficient, leading to a
reduction in the actual man-time and costs for performing protocol feasibility assessment,
patient identification & recruitment, and study conduct, including SAE reporting.
The significant efficiency gains expected with the EHR4CR platform would translate into
substantial added value for pharmaceutical industry.
The CBA model uses robust probabilistic sensitivity analyses (Monte Carlo Simulations)
The CBA model assumes the adoption of EHR4CR services at project completion,
followed by a swift and scalable market penetration across Europe thereafter.
The EHR4CR CBA methodology and results to be submitted to an
international scientific platform of interest (early 2014)
A SCALABLE SUSTAINABLE
EHR4CR Business Model Simulation
Conclusions
Using a EHR4CR Service Provider perspective, and market
assumptions validated by experts opinions, the advanced
modelling simulations suggest that:
The EHR4CR business model appears profitable and sustainable over a
five-year time horizon
The model uses robust probabilistic sensitivity analyses (Monte Carlo
Simulations)
The business model simulation assumes the adoption of EHR4CR
services at project completion, followed by a swift and scalable EHR4CR
market penetration across Europe thereafter
A SCALABLE SUSTAINABLE
NEW BUSINESS
OPPORTUNITIES IN
THE EHR4CR
Transform use of health care data to solve clinical
research bottlenecks
Supplier in new arena connecting hospitals and clinical
researchers
Scope for differentiation through provision of new services and
functionality
Scope to develop new platforms
Opportunity to develop new business channels
NEW BUSINESS OPPORTUNITIES IN THE EHR4CR ECOSYSTEM
What does this mean for stakeholders in the
ecosystem?
Customers will have confidence in the service
Secure, standardised platform specifications
Accredited software and data sets
Privacy protection/legal and ethical issues are handled within the specifications and governance environment
Free market provides opportunity to be competitive and innovative
Develop new, differentiated services
Immediate and profitable business opportunities
New functions/services can be developed at very affordable cost (e.g. If an EHR vendor wants to offer new functionality he can rely on the EHR4CR specs gaining development time and cost)
Establish pilots in collaboration with EHR4CR
EHR4CR seeking collaborations and connections with hospitals and service providers
Develop and refine existing three services
NEW BUSINESS OPPORTUNITIES IN THE EHR4CR ECOSYSTEM
WRAP-UP
AND OUTLOOK
Georges De Moor,
EuroRec
A quick recap….
High unmet need for paradigm shift in
management of clinical trial data
Integration of clinical research data with
patient health records (EHR) will remove
bottlenecks and increase flow of
innovation
EHR4CR has:
identified and addressed key challenges
developed technical solutions, sustainable
business model
New opportunities for service providers
and data providers
NEW BUSINESS OPPORTUNITIES IN THE EHR4CR ECOSYSTEM
What next?
Further development of the
platform
Further pilots
Governance: establishment of the
EHR4CR Institute
For further details, or a
preliminary discussion on next
steps please:
Speak to an EHR4CR
representative at the exhibition or
Contact:
Geert Thienpont (EuroRec)
www.ehr4cr.eu/contact.cfm
NEW BUSINESS OPPORTUNITIES IN THE EHR4CR ECOSYSTEM
Conclusions
Engagement from stakeholders (e.g. pharma, data
providers, industry…) is key to the sustainability of
the EHR4CR services
Priority will be given to recruiting hospitals as
reference EHR data providers connecting to the
EHR4CR platform
Stakeholder engagement activities in 2013-2014
two Stakeholder Awareness Conferences in
Brussels in 2014 (first one on April, 9 in Brussels
at EC premises)
Communications activities in 2015
STAKEHOLDERS Data providers, pharma
industry, academic research institutes, new
service providers (including EHR/EDC vendors), policy makers,
governmental and regulatory agencies Stakeholder awareness
conference with all stakeholders (focus on
hospitals) April 2014
Work with EFPIA members to engage 50-70 hospitals
across Europe,
representing most relevant disease areas and clinical
Can you help realise the vision to transform healthcare?
Sustainable, value-added solutions for the
trustworthy re-use of e-Health data and information
Accelerate medical innovation
Q&A AND
DISCUSSION