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


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


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


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


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


Consortium


What does that mean for a DM?

Not a lot yet

But more to come …..


A NEWBUSINESSOPPORTUNITY


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


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


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


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


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.



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 ………….


USING EHRS TOREMOVEBOTTLENECKS,IN PRACTICALTERMS


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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EHR becomespatient datarepository tostreamlineclinical trials


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



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 ………….


MAKINGINTEGRATEDEHR4CRA REALITY


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


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


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


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


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)


Protocol Feasibility

Select sites ofinterest

Launch queries Analyse results

Accept Execute

Edit EligibilityCriteria


End user view of the application:Protocol Feasibility Service

query workbench


End user view of the application:Results



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



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?



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.


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


Q&A ANDDISCUSSION

32


BACK UP SLIDES

33


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)


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


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


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


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


A SCALABLESUSTAINABLEECOSYSTEM


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?


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)


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


What next?

Further developmentof the platform

Further pilots

Governance:establishment of theEHR4CR Institute

NEWBUSINESS

OPPORTUNITIES IN THEEHR4CR

ECOSYSTEM

Electronic Health Records for Clinical Research

Plans for 2014 and 2015

44

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

the imi ehr4cr initiative

Documents