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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

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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).

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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:comms@ehr4cr.eu

  

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