Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
Primary and secondary use of EHR systems:
Enhancing clinical research for better health and high quality healthcare
Recommendations from STREAM A. Interaction Model
Isabelle de Zegher, co-chair, Novartis, EFPIA
Georges De Moor, co-chair, EUROREC
Marc Peeters, rapporteur, Roche, EFPIA
Note: This document reports the work of a workshop on interaction model and organizational
aspects in the context of Primary and secondary use of EHR systems. The recommendations
included will develop as the work continues and should be read as a work in progress. Any
comments should be sent to the co-chairs.
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
Table of contents
1.
SCOPE AND OBJECTIVE ........................................................................................... 3
1.1
Background......................................................................................................... 3
1.2
Details on use case ............................................................................................. 4
1.2.1
Patient recruitment ............................................................................... 4
1.2.2
Electronic data capture ......................................................................... 5
1.2.3
Safety.................................................................................................... 5
2.
SUMMARY OF KEY DISCUSSION POINTS ........................................................... 5
2.1
Common Issues .................................................................................................. 5
2.1.1
Source & quality (completeness & accessibility) of data: .................... 5
2.1.2
Usage of data for “commercial” purpose ............................................. 6
2.1.3
Workflow: how to ensure seamless integration ................................... 6
2.2
Third Party .......................................................................................................... 6
2.3
“Business case” .................................................................................................. 7
2.4
Framework for interaction .................................................................................. 7
3.
RECOMMENDATIONS ............................................................................................... 8
3.1
Develop Service definition for EHR usage ........................................................ 8
3.2
Communication on eHR use and benefits: ......................................................... 8
3.3
Third party: ......................................................................................................... 8
3.4
Collaboration forum: .......................................................................................... 9
3.5
Roadmap............................................................................................................. 9
3.5.1
2008 Milestones description ................................................................ 9
3.5.2
2009 Milestones description .............................................................. 10
4.
CONCLUSION AND NEXT STEPS .......................................................................... 10
5.
APPENDICES ............................................................................................................... 11
5.1
Agenda.............................................................................................................. 11
5.2
Participants to the STREAM ............................................................................ 13
5.3
Details from Brainstorming session ................................................................. 14
5.3.1
Service Definition .............................................................................. 14
5.3.2
Communication .................................................................................. 15
5.3.3
Third Party.......................................................................................... 16
5.3.4
Common Discussion Forum ............................................................... 16
5.3.5
Roadmap ............................................................................................ 17
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
1.
SCOPE AND OBJECTIVE
1.1
Background
There are about 15 different use cases for the potential usage of EHRs in the context of clinical
research as indicated in the following figure (source: Slipstream project). There are no evident quick
wins, but some use cases are more feasible than others.
Clinical
Research
Clinical
Development
1. Genetic
Regulatory /
Safety
3. Clinical Trial Execution
Association and
Linkage Analysis
10. Post-Marketing
a. Connect Patients to Trials
a. Safety /
Adverse Event
Monitoring
b. Data Collection & Mgmt
2. Clinical
c. Investigator Services
Validation –
Target,
Biomarker, and
Diagnostic
b. Pharmacovigilance
d. Compliance
e. Placebo Populations
c. P-Epi & Data
Mining
Prioritized High-Level Use Cases
Commercial
12. Pharmacoeconomics
13. Marketing
Comparative
Studies
14. Pharmaceutical/
Disease
Management
Programs
4. Clinical Trial Simulation
15. e-Prescribing
5. New Indication
11. Manufacturer’s
Identification
Recall
6. Interim analyses
7. Personalized Medicine – Pharmacogenomics
8. Outcomes Studies
9. Disease and Care Management Modeling
Today however there is insufficient communication: clinical care and clinical research are two
totally separate “electronic worlds” (except for some aspects of EDC) that would benefit by
“breaking the wall” to get to real electronic data exchange
Patient recruitment
GP’s Office
GP’s Office
Clinical trial simulation
GP’s Office
GP’s Office
New indication identification
Personalized medicine
Pharma Industry
Hospital
Hospital
Pharmacovigilance
GP’s Office
Pharmaco-economics
Pharma Industry
GP’s Office
ePrescribing
GP’s Office
Hospital
Hospital
GP’s Office
Predictive safety
Pharma Industry
Pharmaceutical/disease management
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
To break the wall, technology and technical standards (discussed in Stream B) are necessary but not
sufficient. We need as well to clarify the legal hurdle (discussed in Stream C) and the organizational
aspects, including financial aspects.
Benefits of EHR integration for clinical research are MAJOR; but the costs are ALSO major if we
keep the current interaction model: “one hospital/one sponsor” , representing “n to m” electronic
interfaces.
The basic questions that were addressed to the team A are:
 How to adapt interaction models & processes to ensure benefit at affordable cost?
– Should internal processes change both in providers & sponsors organization ?
– Should we define new roles and new skills ?
– Should we put in place new actors such as a third party ?
 How to build a common vision across Health Care to implement these changes
– How can we build a shared understanding of the needed changes
– How can we build a communication forum across Health Care to ensure effective
implementation ?
1.2
Details on use case
Three use cases were proposed to the participants – with more specific questions
 Patient recruitment
 Electronic data capture
 Safety
1.2.1
Patient recruitment
Scope
There are different components in patient recruitment
 Evaluation of protocol feasibility based on availability of patient population as specified by
inclusion/exclusion (i/e) criteria. The ability to do this more effectively before starting a
study allows more “feasible” protocols to be designed and therefore to move faster in trials
 Identification and enrollment of investigators who have patients with identified i/e criteria.
There is no benefit to this step – taken alone; identification of patient and investigator does
not guarantee actual patient recruitment.
 Actual enrollment of patient within a study – following evaluation of i/e criteria
Protocol
feasibility
Investigator
enrollment
Patient
enrollment
Potential changes required for more effective use of EHR
 New roles and processes
– Within sponsors, there is a need to generate protocols in a more“structured” way
(i.e. with computable i/e criteria that can easily be checked across different EHRs)
– Increase IT skills/collaboration during the whole process
 Would a third party be useful?. If yes which type, which services ?
– A third party could decrease constraints related to privacy issues (this needs to be
verified by Stream C)
– A third party could decrease cost of technical integration (going from “n to m”
interfaces to only m)
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
– A third party could provide additional services (act on behalf of caring physician,…)
to speed up the process
1.2.2
Electronic data capture
Scope/Issues.
Today it is estimated that about 80% of the data needed for clinical research are already
collected in clinical care (paper or electronic format). How can we have easier access to these
data, what about the additional “new” data (integration and ownership)?
Potential changes
 New roles and processes
– Should we have a tighter integration of clinical care and clinical research processes
within the provider organizations ?
– How to “seamlessly” adapt EHR for “new” data acquisition ?
– Any changes in the role of CRA versus investigator ?
 Would a third party be useful. If yes , which services ? Would it be another type of CRO ?
1.2.3
Safety
Scope
 pre-launch versus post-launch
 Signal detection versus Adverse Events reporting
Potential changes
 How do we ensure that we have “validated” information on drugs ACROSS Europe to
ensure correct imputation
 To enable predictive safety with effective data mining – assuming data can be pooled and
integrated within existing EHR databases – are the current types of organizations, skills and
processes right ?
 Do we really need to have electronic data exchange or should the sponsors work directly
with the providers within their organization (no need for data exchange)
 What is the impact on pharmacovigilance ? Should we revise the process ?
2.
SUMMARY OF KEY DISCUSSION POINTS
All presentations will be available at the following address
http://www.eurorec.org/EHRWorkshop/model.cfm?selection=model&actief=EHRWorkshop
(additional presentations from the other streams are also available at the same site).
In the following we only summarize key discussion points, consolidated during the workshop across
the 3 uses case
2.1
2.1.1

Common Issues
Source & quality (completeness & accessibility) of data:
Data coming from providers/clinical care : most of the data are coming from billing
o Registry & billing (information available as well within payers): 90% in EU
o CPOE: 18% in Sweden… (if this is available + possible to do safety)
o Ambulatory eHR system: 2% in Sweden
o Clinical data repository: starting….
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
=> information – such as knowledge of AE - is available in text BUT NOT available in in
structured form in EHRs.
=> possibility to increase with financial incentive ?

Data coming from clinical research (clinical researchers in provider organization, pharma)
o Clinical research data Clinical trial Data are there but not available – pharma would
be open to make available protocol and meta-data (such as class side-effect) but not
results DB
o What should be ready to share ? GTB DB from AMIA is not a success
Clinical care: GIGO (Garbage In Garbage out)
Clinical research: GIGO (Gold In Gold Out))
=> SIGO (Silver In – Gold Out)
2.1.2



2.1.3


Usage of data for “commercial” purposes
We need to identify better sources of available data => we do not even a catalog of data;
need to have a typology of the data as well
Need to change mindset and culture: clinical research leads to improved care => it should
not be considered as a “secondary” use !
Currently we need authorization to access the data for usage which is not the original use,
e.g. Informed consent => takes time, puts excessive load on daily practice.
o We should put in place solutions such as preview mechanism, financial reward, work
delegation possible
o Do we really need informed consent in a world where physicians and sponsor are
“responsible” parties….
Workflow: how to ensure seamless integration
EHR versus eCRF: How to ensure seamless integration of clinical care and clinical research
as a continuum rather than two different entities with redundant patient data entry
How to monitor data for AE that will come in the future => how to ensure that data from
clinical research are integrated into clinical care (will be critical mostly for devices in the
future)
2.2
Third Party
Different potential models for third parties (several already in place in Europe)
 public : money from government;
e.g. GPRD: model of “real-world” data collected longitudinal record
 business (e.g. CRIX), public-private partnership, non –profit but self sustained
e.g. CRIX: model of sequencing: first efficacy and safety before launch and then monitoring
data collected as part of existing process
 academic: research money (from grants and government)
e.g. Erasmus University Rotterdam – hospital
Which of the model offers the most trustworthiness and the highest quality of data (accuracy,
completeness)?
Difficulties to set up a third party ?
 political environment more difficult than technology !
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007

technical integration and legal aspects - critical to have a Trusted Third Party to solve the
different technical and legal aspects
 feasible in the pharma/regulatory world – but for EHR integration would require gradual
integration
Several third parties of different types already exist in Europe => need to make inventory .
possibility of federation of existing third parties ?
What are the requirements/services for a third party
 Technical integration
 Legal “guardian”
 Third party data can bring as well services to patients ? usage of patient as placebo data ?
 Handles all data versus data on demand and build
 Intermediate between hospital and payers
2.3
“Business case”
Benefits of EHR integration is potentially huge – faster and more efficient clinical development
process, increase safety – but the cost of a fully scalable solution may be even higher unless we
change the way we work.
Who makes the money ? when hospital and GP – and patients - become aware of the value of their
data the model may change – however there is value on the data only if they are pooled not at
individual level !
 The society benefits NOT the individual
 EU will work as there is collective health – in US it is the individual protection first however
there is still a benefit to share the data
2.4
Framework for interaction
We need a paradigm shift
 Quality of data : From low data, reactive high cost – to high data pro-active
 Data mining – hypothesis testing can be possible – only if there is a strict governance
process: how can we go hypothesis strengthening in the real word
 Availability/sharing of data:
Definition of interaction model is composed of
 Description of the processes & workflow - where it applies (from end to end – with the need
for change from the current situation to the future)
 Definition of Pre and post conditions
 Description of input and output (concepts and controlled terminologies)
Implementation of new interaction model will require a framework with
 Governance structure of transformation
 Budget – with realistic scope
 Organization & People and stakeholder management
 Technology infrastructure
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
3.
RECOMMENDATIONS
Four focus areas were identified during the workshop and further elaborated. In the following we
only provide a summary of the ideas (see appendix for further details)
3.1
Develop Service definition for EHR usage
Scope
 Which type of services must be defined to allow for EHR integration.
 How de we define and implement services, how do we get a holistic approach
(people/process, technology and business case).
 How can IT vendors be involved as a consortium (integrating EHR vendors and EDC
vendors); need to clarify role of certification
 We need to understand which type of data are available (catalogue of data ?)
 We need to start with a pilot and get more input from pharma & health care (only one step
but a piece of the puzzle) – define interaction model
 Proposal is to support the CRFQ project (clinical research filter query – see presentation
from Mead on site); with links between GPs, hospitals and vendors to ensure applicability
of services like CRFQ across different computer systems
Practical next steps: start with a pilot building upon CRFQ to learn on how to work together for
defining services in a more structured way
 Evaluate implementation of a standard service such as Clinical Research Filtered Query
(CRFQ). A request would be issued by a clinical research organization, be forwarded to
Health Care providers (hospital, third parties like GPRD, other regional or national
Databases) to evaluate patient population against specific criteria.
 Evaluate business process changes in the context of protocol feasibility, patient recruitment
and safety monitoring
 Evaluate business case – benefits and cost for full implementation across the health Care
chain
 Evaluate how to work together as a Health Care “continuum” to further defined service in
the clinical research area
3.2
Communication on EHR use and benefits:
Scope
 One of the concerns is the time required to have patient approval for usage of data –
communication on the value of using pooled/integrated EHR data should be communicated
 We need to re-insure patient representatives/ press / media that there is nothing that should
frighten the public in using their data
=> explain why we need access to data and decrease the worry
=> explain the semantic / decrease misunderstanding/emotions
Practical next steps: need to defined strategy and communication plan – no precise action taken
yet
3.3
Third party:
Scope
We need to clarify the following aspects
 what are the existing third parties in Europe,
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007



how do we set up a third party in Europe,
what should be the business model
how to integrate services - like CRFQ - within third party and related process changes =>
will this accelerate the implementation ?
Practical next steps:
 Need to define a Third party – taking into account technical (from Stream B) and legal (from
Stream C) requirements.
 Agreed in plenary to start a project working on the definition of a European Third party
3.4
Collaboration forum:
Scope
 We need to have a structured way of collaborating – currently HC providers and pharma do
not have a common collaboration forum.
 We need to clarify the mission statement and governance model of this collaboration forum
and identify possibility to expand existing collaboration forum – rather than to build and
maintain another one
Practical next steps
 Need to follow up between European Commission, EUROREC, EFPIA
3.5
Proposed Roadmap
Operational level
CRFQ pilot
Strategic level
2008
Strategic plan
2009
CRFQ in production
(onco ?)
Catalog of data
2010
2011
CRFQ model as basis across EHR
Free access to catalog of data
EU Third Party
Kickoff
or NO GO
Public DB with info
on medicinal products
First Communication
1st draft
guidance
IMI call
3.5.1



2008 Milestones description
CRFQ pilot
Agreed project definition, catalogue of available resources, strategy for further funding,
success criteria: CRFQ Proof of concept complete, Communications strategy implemented,
Positive feedback
Communication : publish within `news monitor`
Catalogue of data
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007



3.5.2




o Develop a catalogue of databases, built from EHRs, that are currently available
across Europe for researchers – both within the source institutions and beyond – to
access and use.
Euro-EHR data compendium adopting UK example
Develop strategic place
Capture case studies + best practices + develop 1st draft guidance
Have at least one large scale Academia – Hospital – IT industry – Pharma project topic
defined within the IMI call process
2009 Milestones description
I/E CRFQ implemented on existing EHRs (Cancer)
o CRFQ operational in 3 sides
o CRFQ as DSTU in Q1 2008 + OMG RFP in Q2 2008
o One service in pilot , is the basis of learnings needed to build roadmap
Collaboration Forum in place
o Organization / framework for decision making in place
o Charter agreement of common discussion forum
o Definition of an IHE Technical Framework for clinical research (to be able to test
something at the 2009 or 2010 Connectathon
Go / no go understanding of need and value of third party
o Mobilize Pharma industry to identify / launch a common EHR platform (summit)
o Third party business case assessed + deliverables of Discussion Forum achieved
o Public template for workflows within study protocols
Pilot of first service
2010 - Milestone description
 CRFQ as standard connectors - Run a pilot study on a fully integrated EHR across
boarders; Assess need for a follow-up project
 European free official database of drugs, usage, important adverse events, brandname in
each country, unique ID etc.
 Catalogue of data available freely. Publish answer to the question `how much data is
available in EHRs that can be used directly in clinical trials`
4.
CONCLUSION AND NEXT STEPS
Focus up to February 2008 (next meeting) will be on
o Developing a project around of CRFQ (technical aspects being developed under HSSP,
project to focus on testing, organizational aspect and business case).
Project charter to be defined for a kick-off in November.
o Collaborating with stream B on the establishment of a third party
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
5.
APPENDICES
5.1
Agenda
(note: all presentations can be found under www.eurorec.org – see EHR workshop on the left hand
side – then select “interaction model” tab in the page
Thursday 11th October (afternoon)
Time
Title
Author
Overall introduction
14:30 – 14:45 Introduction to the session: participants and expectation G. De Moor,
(15 min)
I. de Zegher
14:45 – 15:05 Lessons learnt on secondary usage of data from the UK
J. Parker
(20 min)
NHS CRC study
15:05 – 15:25 Lessons learnt from CRIX, a third party in place in the
J. Bland
(20 min)
US: interaction model, setting up, benefits and concerns
of several months of operations
Focus on Patient recruitment. Patient recruitment: from today’s paper based process to “24
hours recruitment”” is a technology supported by process changes enough or do we need a
third party to solve legal issues and technical heterogeneity.
15:25 – 15:45 Identifying and recruiting patients for clinical trials in
R. Thwaites
(20 min)
the future: a pharma perspective
15:45 – 16:15 Hospital/Health care perspective
J. van der Lei
(20 min)
16:15 – 16: 30 BREAK
(15 min)
16:30 – 16:50 IT perspective
C. Mead
16:50 – 17:15 Discussion and recommendations for actions
I. de Zegher,
(25 min)
G. De Moor,
Focus on Electronic data capture. Can EHR replace the need for eCRF, what is the impact on
the investigator-clinical monitor roles
17:15 – 17:35 A detail on the process: pharma perspective
H. Donovan
(20 min)
17:35 – 17:45 Hospital/Health care perspective
C. Le Bozec
(20 min)
17:45 – 18:05 IT vendors perspective
JF Penciolelli
(20 min)
18:05
Close of session
18:30 – 19:30 Meeting Organizing Committee
Organizing
BU33 0/54
Committee
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
Friday 12th October (morning)
Time
Title
Author
Focus on Electronic data capture. Can EHR replace the need for eCRF, what is the impact on
the investigator-clinical monitor roles
08:30 – 09:00 Discussion and recommendations for actions
G. De Moor,
(30 min)
I. de Zegher
Focus on Safety. Availability of EHR database and data warehouse: a new safety model ?
impact on the current pharmacovigilance models ?
09:00 – 09:20 A detail on the process: pharma perspective
S. Markel-Fox
(20 min)
09:20 – 09:40 Hospital/Health care perspective
C. Lovis
(20 min)
09:40 – 10:00 IT vendors perspective
Sarah Payne
(20 min)
10:00 – 10:20 Authorities perspective
N.N. EMEA,
(20 min)
TBC
10:20 – 10:40 BREAK
(20 min)
10:40 – 11:10 Discussion and recommendations for actions on safety
I. de Zegher,
(30 min)
G. De Moor
Consolidated recommendations (Identify person responsible for reporting during plenary)
11:10 – 12:30 Key messages from the different focus areas
G. De Moor,
(1h 20 min)
Consolidated recommendations
I. de Zegher
Practical next steps
12:30
Close of session - LUNCH
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
5.2
Participants to the STREAM
James
Michael
Georges
Isabelle
Hugh
Danielle
Christel
Christian
Suzanne
Charlie
John
Sarah
Jean Francois
Marc
Barbara
Rob
Johan
Alain
Tim
Bland
Dahlweid
de Moor
de Zegher
Donovan
Dupont
Le Bozec
Lovis
Markel-Fox
Mead
Parkinson
Payne
Penciolelli
Peeters
Tardiff
Twaites
van der Lei
Venot
Buxton
CRIX
Agfa Healthcare
Eurorec
Novartis
Accenture
BMS
APHP / INSERM
Geneva Univ Hospitals
GSK
NCI – Booz Allen
MHRA, GPRD, UK
IBM
Oracle
Roche
Parexel
GSK
Erasmus Rotterdam
SMBH
EMEA
james.l.bland@crixintl.org
michael.dahlweid@agfa-healthcare.fr
Georges.DeMoor@UGent.be
isabelle.dezegher@novartis.com
hugh.c.donovan@accenture.com
danielle.dupont@bms.com
Christel.Lebozec@spim.jussieu.fr
christian.Lovis@sim.hcuge.ch
Suzanne.L.Markel-Fox@gsk.com
mead_charlie@bah.com
John.Parkinson@mhra.gsi.gov.uk
sarah.payne@uk.ibm.com
jean-francois.penciolelli@oracle.com
Marc.peeters@roche.com
barbara.tardiff@parexel.com
rob.m.thwaites@gsk.com
j.vanderlei@erasmusmc.nl
avenot@smbh.univ-paris13.fr
Tim.Buxton@emea.europa.eu
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
5.3
Details from Brainstorming session
Four topics were identified (service definition, communication on eHR use and benefits, third
party, collaboration forum) during the workshop. The participants of the work stream were asked to
provide one specific idea/next step related to each topic – and then to put a critical milestone in the
roadmap.
This is the detailed results. All ideas have been captured and grouped, and reproduced herewith
exactly as written by participants.
5.3.1
Service Definition
How do we define services
 Develop cost/benefit analysis for each and any service
 Case definition service is the key to aggregation across Europe.
 Who is doing it now. Capture the details of the case studies + use learning to define
guidance around governance, people, processes and technologies
 Define a proof of concept and execute a proof of concept implementation strategy
 Specific clinical service definition should be coupled with terminology service definition
since the semantic is a so important issue +++
 In today`s Health Information Systems (the Source level), be it in hospital care or
ambulatory care settings, we need to develop new subsystems, components, modules (with
processes around) to address the specific purpose of research. We need a requirements
analysis. A first step could be to define business functions, content criteria serving as quality
criteria for those systems. Certification can help to bring together Pharma and IT vendors.
 Pharma industry should provide label information in an electronic form, structured so that
the information can be easily handled electronically to develop alerts and guidance…..will
need for example, conditions to be coded (eg ICD) relevant to values to be coded (LOINC
etc.)
How do we define services: expand on CRFQ pilot
 Define a `standard template` for service definition taking CRFQ as an example
 Bring CFRQ / IHE together in a specialized IHE profile (EC funded workstream)
 Review CRFQ RI + continue to expand UC catalogue around CRFQ usage context
 Implement CRFQ at a few sites
 Test CRFQ I/E on existing data sources (EMR/EHR/EPR)
 Test CRFQ safety model in 2-3 different systems
 Apply CRFQ + idea to the Pharma Clinical Trial Databases
Understanding available data
 Catalogue and sort by usages the available info sources;
 Develop a catalogue of databases (1) short term (2) medium term. Develop a catalogue of
databases (built upon EHRs) that (1) are currently available for researchers to use – eg
review safety submissions and publications to find the databases to include in version 1, then
(2) it could be available, but have not so far been used outside their source institutions – will
need a survey
 Using CDASH output, determine how much is available in EHRs at representative hospitals
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
Which types of services
 Pharma industry to make its product information dissemination computable
 Implementation of eCRF linked closely to the EHR
 Reporting systems for adverse events closely linked to EHR
 EHR to support EU patient registries for targeted therapeutic areas/diseases in real life
settings and epidemiology studies etc.
 Implement clinical workflows at 3 test sites
 Pharma: use of EHR to conduct drug utilization review, post marketing surveillance and care
gap analysis in real life settings
 Generation of reports of adverse events directly from EHR
 Access / submission of supplemental information regarding patients clinical care experience
around an adverse event on demand as part of investigation of AE for expanded databases
etc.
Services related to drug identification
 Drug identification + Drug structured information
 A single drug dictionary globally
 Drug Lexicon / id
 Drugs enter drug dictionary at start of Phase 3 trials
5.3.2
Communication
How do we communicate: setting up strategy
 Declaration of Helsinki: Citizens OR Data Subjects
 Define the strategy: Target stakeholders, Messages to be passed, Catalogue of channels,
Goals of the strategy, funding model
What do we communicate
 Use case studies + success stories to lobby key stakeholders + identify the stakeholder`s
decision makers
 Position EHR as a tool to facilitate optimal disease management, to insure patient safety and
to maximize health outcomes
 Regulators, Patients, and Pharma to accept the notion of risk
 Minimum requirements for Privacy Enhancing Technologies
 Encourage patients understanding and involvement by use of `healthspaces`
 Introduce specified medical research use of clinical care data to healthcare IT community,
the software vendors ans system integrators
How do we communicate: communication plan (stakeholders, media, timelines, ..)
 Make sure that EFPIA taskforce outcomes are circulated among Member State Governance
bodies by mid 2008
 Use the `patient – centered` EHR model to engage Pharma
 Engage patients as stakeholders in a revision of Helsinki requirements
 Weekly / monthly `news monitors` email to build awareness of incremental steps being
made
 Pharma / Healthcare org JOINT communiqués on data sharing
 Communication to patients: integrate to eHealth Initiatve
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007
5.3.3
Third Party
Business models
 Implement service delivery platforms (SDP) as FMVK able to deliver billable services
(secondary use)
 Pharmacists are missing
 Draft binding set of principles and guidelines that are supportive of R&D that regulate the
(1) access to patient / claims data (need for protocols, objectives and methods review,
approval,..) and (2) publishing of results (need for methods and statistical review,
approvals,…)
 Business entity that can establish business model, write business plans, and raise money to
develop and deliver services for multiple use of electronic health records (see them as
product offerings that might be developed over time)
 Document business case from perspective of all stakeholders
 At the European level should be : driven by Healtcare Authorities, with scientific board from
Academia, and built by IT vendors, using standards : IHE and CDISC, HL7,..
 Business Place Pharma, IT Vendors, Governance, Providers, as a template / funded research
project
Setting up the Third Party
 Survey / Inventory across Europe: available / under development, business model , financing
 Accept that there will not be a EURO-EHR common definition for at a minimum 5 years
……so federate
 There are many potential third parties each with different roles eg `secure data repositories`,
facilitators, providers of shared IT eg processing power. We need to understand who they are
and their role
Type of services
 Promote catalogue of data
 Stimulate and catalogue GPRD – like initiatives ans list their mandate constraints vis-à-vis
research work
 Set / common EHR platform of interest for the pharma industry with patient access focus
(EHR to shorter R&D time, facilitate preparation of valuee propositions to payers and
increase patient access.
 Build / Assemble cross-organisation CRFQ test data sets
 Joined research from different databases
5.3.4
Common Discussion Forum
Scope and objective – mission statement
 Defining conditions for making it possible the access of EHR to various stakeholders
 Define terms of relevance, include a fixed term, mandate deliverables, ask CEN to champion
 Purpose of the Discussion Forum is to provide a place where all stakeholders can be invited
(from across Europe) to shave information on initiatives and to identify areas where
collaboration will lead to mutual benefits. Next step: identity and approach `umbrella `
group where this forum would belong.
 Decide upon ONE framework as the official` EHR related one ie enhance it with Clinical
LLSE.
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007

Unique EHR with primary care and hospital data in every country of the European Union
(political decision)
Forum/framework/governance:
 Organisational entity of recognized leaders that will develop executable strategic plan and
build trust in one another
 Build new group to increase efficiency
 Common discussion : overall it needs governance , it needs to be a place where all
stakeholders can contribute , it might include a number of for a to drill into the details
 Assemble a multi-disciplinary team and produce RI of scope / vision document and
governance documents
 Governance of the uses of the data – each protocol , an ABSOLUTE
Candidate groups
 IHE is excellent framework with good involvement of all actors (users, IT vendors,…) of
EUROPEAN countries. Create a SPECIFIC DOMAIN dedicated to CLINICAL
RESEARCH (to define the needs and workflows)
 Peer Review process among Database providers internationally
 CDISC eSDI
 IT vendors Information + Use existing patient associations to inform about secondary use.
 EUROREC – pharma not present/active yet
How to do
 Involve EHR vendors, make them aware of Research Requirements
 Develop EHR applications (tailored to address top priorities / stakeholders) using a patientcentered model as common discussion framework.
 Work with IT industry to agree the common core data elements / standards to be included in
applications
5.3.5
Roadmap
Group 1 (short term) - 2008
 CRFQ pilot
Agreed project definition, catalogue of available resources, strategy for further funding,
success criteria: CRFQ Proof of concept complete, Communications strategy implemented,
Positive feedback
 Communication `news monitor`
 Develop a catalogue of databases, built from EHRs, that are currently available across
Europe for researchers – both within the source institutions and beyond – to access and use.
Euro-EHR data compendium adopting UK example
 Develop strategic place
 Capture case studies + best practices + develop 1st draft guidance
 Have at least one large scale Academia – Hospital – IT industry – Pharma project topic
defined within the IMI call process
 AER on existing EHRs
Primary and secondary use of EHR:
Enhancing clinical research
Brussels 11th and 12th October 2007

Some practical , pragmatic, reachable milestones with direct benefit in EHR
Group 2 (mid term) – 2009
 I/E CRFQ implemented on existing EHRs (Cancer)
o CRFQ operational in 3 sides
o CRFQ as DSTU in Q1 2008 + OMG RFP in Q2 2008
o One service in pilot , is the basis of learnings needed to build roadmap
 Collaboration Forum in place
o Organisation / framework for decision making in place
o Charter agreement of common discussion forum
o Definition of an IHE Technical Framework for clinical research (to be able to test
something at the 2009 or 2010 Connecthatlon
 Go / no go understanding of need and value of third party
o Mobilize Pharma industry to identify / launch a common EHR platform (summit)
o Third party business case assessed + deliverables of Discussion Forum achieved
o Public template for workflows within study protocols
 Pilot of first service
Group 3 (long term)
 CRFQ as standard connectors
 Run a pilot study on a fully integrated EHR across boarders
 Assess need for a follow-up project
 European free official database of drugs, usage, important adverse events, brandname in
each country, unique ID etc.
 Publish answer to the question `how much data is available in EHRs that can be used
directly in clinical trials`
 The Connectathlon: test the first integration profile dedicated to clinical research `patient
recruitment`or including a CRF in EHR`
 Executing Entity in place capturing and aggregating supplemental medical record
information of selected AEs