Download - THE IMI EHR4CR INITIATIVE
Electronic Health Records for Clinical Research 1
THE IMI EHR4CRINITIATIVE
French DMBParis, France, November 7 2016Johann Pröve, Clinical Data Management Consulting
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Agenda
Session
Introduction to IMI EHR4CR (Electronic Health Records ForClinical Research)
Protocol feasibility
Site & patient identification
Study conduct & SAE reporting
The impact on the clinical data management function
I would like to express my appreciation to all consortiummembers who helped putting together this presentation
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Objectives of the EHR4CR Initiative
Demonstrate the need to create a new model forclinical research to transform development ofand access to innovative medicines for patients– in full compliance with all relevant ethical, legaland privacy protection standards and policies
Outline a new business model that leveragesadvances in health information technologies
Demonstrate a technical and commercialopportunity within this new health informaticstechnology ecosystem
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What is the IMI?
A unique public-private programme co-funded bythe European Commission and the EuropeanFederation of Pharmaceutical Industries andAssociations (EFPIA)
A pan-European collaboration that bringstogether large biopharmaceutical companies,patient organisations, academia, hospitals,small- and medium-sized enterprises (SMEs) andpublic authorities
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What is EHR4CR?
One of the largest Europeanpublic/private partnership projectsin this area
5-year project (2011-2016)
Budget of € >16m
Assess the re-use of EHR data for
protocol feasibility,
patient / site identification,
study conduct & SAE reporting
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What does that mean for a DM?
Not a lot yet
But more to come …..
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There is a need to bridge the gap
We have imagined an environment where de-identifiedpatient data can be re-used within healthcare andresearch for clinical research purposes…
Across countries
Across systems
Across sites
…to speed up protocoldesign, patient recruitment,data capture, safety reporting…
Patienthealth records
De-identifieddata forClinical
Research
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Protocol design / Protocol Feasibility basedon estimates
Protocols governedby establishedstandards
With very limitedaccess to actualpatient data, trialdesign is based ondiscussions withexpert clinicians
Increasedamendments, slowerthan expectedenrolment, costlychanges to add newsites and countries,even failed trials
A third ofprotocol
amendmentsare
avoidable1 ,at a cost of$0.5m per
amendment.2
How longwill the trial
take?
Will we be able to recruitthe necessary volume of
patients in order tocollect data with
sufficient statisticalpower to meet regulatory
requirements?
Where will wefind sufficient
numbers of theright patients?
Do theinclusion/exclusion
criteria makesense?
1. Drug Information Journal, Vol 45, 20112. Industry Standard Research, 2010
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Patient recruitment a majorcause of trial delays With no searchable patient database, identifying and recruiting suitable
patients and trial sites are a major cause of trial completion delay
Delayed trials waste costly resources and slow access to new drugs
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 2007.3. Beasley, “Recruiting” 20084. Tufts -http://clinicalperformancepartners.com/wp-content/uploads/2012/07/Fixing-Feasibility-Final-Jan-2012.pdf
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Study conduct and data entry (EHR & EDC)
Clinical trial data are manuallyentered into dedicated electronicclinical trial systems (EDC) and thesame information is often alsoentered into EHR systems
Cumbersome and slowprocesses
Transcription inconsistencies
Reporting delay of e.g. SeriousAdverse Events
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 areentered into the patient’shealth record, the clinicaltrial EDC system, and,possibly, a third papercopy1
Over
70%of data are duplicatedbetween EHR and clinicaltrial systems2
Investigational sitesestimate that over
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Need for re-use of electronic healthrecords
Improveefficiency
Managecomplexity
Improveadverseevent
reporting
Make newmedicinesavailable
faster
Access to patient data is key toremove bottlenecks in clinicalresearch
Fundamental problem is how to accessand share electronic patient healthrecords
Disparate and separate systems
Patient care, laboratory, pharmacy, etc.
Different purpose
Patient care and/or providerreimbursement
Multiple formats
Narrative, images (X-ray), recorded datafrom instruments (e.g. ECG), geneticsequence data, etc.
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What does that mean for a DM?
New job opportunities in the area of protocolfeasibility management ?
New interface between EDC and EHR data ?
More sources of data for clinical trials ?
New medical coding mapping requirements ?
Different query management process ?
But more on the horizon ………….
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Access to health records speeds up protocoldesign, patient recruitment, data capture &exchange (1)
Evaluate patient populations in study setup
Query EHR database to establishnumber of potential candidates
Improve and validate study designs
Accelerate patient identification andrecruitment
Query EHR database to select sitesand identify and recruit patients
Implement study screeningparameters into patient registrationand scheduling
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Access to health records speeds up protocoldesign, patient recruitment, data capture &exchange (2)
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Capture clinical trial data
Incorporate study-specific datacapture as part of routine clinical care
Auto-populate study data elementsinto case report forms from other partsof EHR database
Minimise duplication of data collection
Exchange clinical trial data
Facilitate Serious Adverse Eventreporting
Efficient patient data collection forstudy conduct
EHR becomespatient datarepository tostreamlineclinical trials
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What does that mean for a DM?
Interactions with site staff on data capture inEHR system?
Agreement on standards used for data capture inEHR system?
Cooperation with other sponsor companies onjoint standards ?
More to come ………….
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Ethical, privacy and legal challenges
Use of patients’ medical information forsecondary purposes
Patients need to know data is heldsecurely and privacy ensured
Must be trustworthy and transparent
Laws and regulations differ forprocessing personal data in differentcountries (sometimes even States)
Additional laws regarding medical research
EU Data Protection Directive 95/46/EC
The EU Data Protection Regulation
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Our key design principles (1)
Analyze de-identified health records atparticipating hospital sites
Platform only connected to dedicatedrepository approved by each hospital forEHR4CR use
For protocol feasibility and patientidentification/recruitment, only patientcounts (totals and sub-totals) arereturned from each hospital to thecentral EHR4CR Platform, never patientlevel data
Platform never stores or communicates dataabout single data subjects
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Our key design principles (2)
Data about individuals, who might beinvited into a study, remain internalto the hospital and abide by its localgovernance rules
Only treating physicians can re-identifycandidate patients
EHR data is only shared - within thehospital - with a clinical researchteam if the patient has given aspecific consent
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Ensuring robust governance
Only approved users are formally registered andgiven secure log-in credentials
Users have no means of requesting or obtainingpatient level data through the services
Even patient numbers are suppressed if the numbersare very low
State of the art information security measures areused throughout
Audit logs are captured at key communicationspoints:
Pharma sites, within the Platform and at hospitals
A Code of Practice and Standard Operating Ruleswill govern the actions of all parties using theEHR4CR services
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Protocol Feasibility Service pilot Tested viability and performance of
EHR4CR platform to support protocolfeasibility service
o 11 major hospitals in five countries
o EHR4CR-compliant data warehouses wereestablished at all pilot sites
o Large set of eligibility criteria from EFPIA trialsanalysed to identify commonly used data elements
(75 EHR data elements)
o De-identified data from >five millionpatients was loaded for these elements into
local EHR4CR-compliant data warehouses as faras 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)
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Protocol Feasibility
Select sites ofinterest
Launch queries Analyse results
Accept Execute
Edit EligibilityCriteria
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End user view of the application:Protocol Feasibility Service
query workbench
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What does that mean for a DM?
Get involved in similar activities ?
PACeR (Partnership to Advance Clinical electronicResearch)
MHRA CPRD (Clinical Practice Research Datalink)
Intersystems working on re-use of EHR data
IBM WATSON looking into options to screen throughEHR data and use the results for clinical research
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What does that mean for a DM?
No paper CRFs anymore ?
Less query management since data may becleaner ?
Hardly any SAE reconciliation necessary?
Fewer centers with patient data and fewercenters without any data ?
More remote data review with more sophisticatedtools compared to today?
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What does that mean for a DM?
More programming skills required ?
New coding systems like SNOMED, ICD9, DRG,LOINC to be learned ?
Additional language skills required ?
Additional interactions with other suppliers andnew customers ?
Overall, the role of the clinical data manager willhave to change, probably to the better.
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Summary
EHR4CR is only one of the initiatives on the horizonlooking into the re-use of electronic health records
It is a difficult undertaking due to many players,applications, requirements, laws involved
Tapping into electronic health records will have an impacton the tasks and skill requirements of a clinical datamanager
Get ready for it; it is different than what we do today,however, it also offers opportunities and a moreinteresting business life
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Technical Platform: what has beenachieved so far?
Protocol Feasibility Service
Architecture description (blue print) andtechnical specifications
A formal and validated Software RequirementsSpecification
First version of EHR4CR platform developed
Platform reference implementation
Evolving information model (commonlanguage)
Based on generic reference models (e.g. ISO/HL7RIM andCDISC/HL7 BRIDG)
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Technical Platform: progressing furtherservices
Patient Identification and Recruitment Service
Software Requirement Specification defined andagreed
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
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Validated solutions
Developed different pilots for validating thesolutions:
For different scenarios (e.g. protocol feasibility)
Across different therapeutic areas (oncology, inflammatorydiseases, neuroscience, diabetes, cardiovascular diseases,respiratory diseases)
Across several countries (under different legal frameworks)
De-identified EHR data from EHR4CR hospitalpartner sites
Validated the platform and proof-of-concept services
Shaped a sustainable business model
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PFS proof-of-concept outcome
Conclusion of defined POC success criteria:
Retrieving information from hospital sites:
Timely response but endpoints without data haltquery execution
Reliability of information returned:
Query modification and re-running of queries:
Transnational platform across systems andhospitals:
Fulfilled 80% of all assessment criteria
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Pilots: Next steps
Assess the next three scenarios
Patient identification – ongoing
Trial execution – end of 2014 – 201X
Serious adverse events reporting – end of 2014 – 201X
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Establishing an integrated EHR4CRecosystem Demonstrating the viability of a sustainable business model
is a crucial first step to success
A sustainable EHR4CR business model must includevarious elements to connect providers and receivers of EHRdata through different services (e.g. patient recruitment)
Is it scalable? How will it befinanced?
How can we guaranteethe integrity of data and
service providers?
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What would a thriving ecosystem look like?
Free market in interoperable EHR4CR softwarecomponents, services and solutions
A growing number of application providers, serviceproviders, data providers
Framework to ensure trustworthy re-use of data
Demonstrable value to ecosystem players (e.g.faster patient access to new safe and effectivedrugs)
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EHR4CR CBAPreliminary Findings
The EHR4CR Cost Benefit Analysis preliminaryfindings suggest that:
Compared to current practices, EHR4CR servicesappear more efficient, leading to a reduction in theactual man-time and costs for performing protocolfeasibility assessment, patient identification &recruitment, and study conduct, including SAEreporting
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What next?
Further developmentof the platform
Further pilots
Governance:establishment of theEHR4CR Institute
NEWBUSINESS
OPPORTUNITIES IN THEEHR4CR
ECOSYSTEM
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Plans for 2014 and 2015
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Engagement from stakeholders (e.g.pharma, data providers, industry…) is keyto the sustainability of the EHR4CRservices
Priority will be given to recruitinghospitals as reference EHR data providersconnecting to the EHR4CR platform
Stakeholder engagement activities in2014-2015 two Stakeholder Awareness
Conferences in Brussels in 2014 Communication activities in 2015
STAKEHOLDERSData providers,
pharma industry,academic research
institutes, new serviceproviders (includingEHR/EDC vendors),
policy makers,governmental and
regulatory agencies
Stakeholderawareness conferencewith all stakeholders(focus on hospitals)
April 2014
Work with EFPIAmembers to engage
50-70 hospitals acrossEurope, representingmost relevant diseaseareas and clinical trial
sites