DEC 3 2015 Mats Sundgren
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Transcript of DEC 3 2015 Mats Sundgren
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Mats Sundgren, AstraZenecaEHR4CR Coordinator
EHR4CR deployment plans inEurope 2016 and beyondSwedish Science Council, Stockholm December 3, 2015
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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 and European hospitals
Governance via The European Institute for Innovation through Health Data
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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…
Patienthealth records
De-identified data for Clinical
Research
as a beginning
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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
1/3 of 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” 20084. 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
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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 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/
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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 REPORTINGPROTOCOL 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
Project graduation
2015
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
2016 – 2017
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
AuditWorkflow
MessagingPlatform
Management
TerminologyServices
Mapping...Local
Applications
ETL
Site dependent process
ApplicationServices
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 PLATFORMHOSPITAL/DATA PROVIDER RESEARCH CENTRE e.g. pharmaceutical company
Protocol feasibility service
Patient recruitment service
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Protocol Feasibility workflow (study design)
Design study (formalize
criteria)
Execute(automated)
Central Platform
Clinical Site
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2
5
Select sites of interest
Launch queries(test study)
Report results
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Analyze results
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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
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1
2 6 9
4 5 78
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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
Initial Services
Installed and used inside the hospital
Central service available to researchers
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InSite central platform screenshotPFS 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 screenshotPFS 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
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
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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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Value for pharma & research organisationsClear 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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THE GOVERNANCE
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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
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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 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
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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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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.
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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
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Efpia Champion Programme summaryThe 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
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CLOSER LOOK AT CONNECTING HOSPITALS
3737CONFIDENTIAL
4-stage Site Intake ProcessChampion 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
NDA
Clinical Partner Agreement
Agreement signoff
3838CONFIDENTIAL
Intake Process
Installation checklist
ETL Preparatio
n
Node Preparatio
n
Connectivity Test
Iterative ETL process, trouble-
shooting and fine-tuning
validation through
the InSite query system
AssessmentDesign &
Explorative test
IT Integration (software, networking, etc.)
Data Integration (semantics)
Planning
Stage 2
Stage 3
Stage 4
3939CONFIDENTIAL
Data of Interest
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
4040CONFIDENTIAL
Data of InterestCategory 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).
4141CONFIDENTIAL
Stage 4: deployment
Data Integration Process
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
Iterative (cooperative) process
Stage 2 Stage 3: planning and agreement
4242CONFIDENTIAL
Integration Example Integration based on existing
reports (data exports)
Lab using local coding system
LOINC conversion provided for top concepts
Full LOINC conversion planned
4343CONFIDENTIAL
CDW
Integration Example
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
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Thank You!Contact us:[email protected]
European Institute for Innovation Through Health Data www.i-hd.eu
Custodix InSite Platformwww.insiteplatform.com
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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
Patienthealth records
Clinicalresearcher
De-identified data for Clinical
Research
www.insiteplatform.com