2014 acdm conference: eh4cr - nextrials · pdf filetitle: microsoft powerpoint -...

EHR4CR – An Innovative Platform and Business

March 2014

Copyright EHR4CR 2014 1

Electronic Health Records for Clinical Research 11

EHR4CR – AN INNOVATIVE PLATFORM AND BUSINESS MODELACDM Annual Conference, 9 March 2014

Richard Perkins, eClinical Forum


The inefficiencies become obvious at the clinical trial interface

Industry-centric growth in ICT

Physician /Investigator

57% of R&D investment is within Clinical Development1

57% of R&D investment is within Clinical Development1

In some countries nearly 90% of all healthcare records

are digital

In some countries nearly 90% of all healthcare records

are digital

Patienthealth recordsClinical trial

research data

Electronic data capture

of Clinical Trial data

Patient Care Data

Over 40% of clinical trial

data are entered into

health record and EDC1

1. Integrating Electronic Health Records and Clinical Trials: An Examination of Pragmatic Issues, Michael Kahn, University of Colorado.


March 2014



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

Patienthealth records

De-identified data for Clinical

Research


A win-win for all stakeholders is key

Pharma, academia, CROs

Clinical trial development will

become more efficientby reducing the time it

takes to bring new drugs to market, thus generating substantial

value

HospitalsAble to participate in

more clinical research programmes,

benefiting their patients

Health authorities

Access to new and better evidence to underpin health

policy, strategy and resource planning

Health community/

governmentsAble to offer improved quality of healthcare

with reduced healthcare costs

EUMore attractive for R&D investment

PatientsFaster access to safe

and effective medicines, improving

health outcomes across Europe


March 2014



The EHR4CR Project brings together stakeholders


Deliverables

Technical Platform

A Set Of Tools And Services

1. Protocol Feasibility

2. Patient Identification and Recruitment

3. Clinical Trial Data Exchange

Business Model

Validated Through Pilots

Different therapeutic areas (e.g. oncology, neuroscience, diabetes, CVS…)

Several countries (under different legal frameworks)


March 2014



Scenario 1: Protocol Feasibility

With no, or limited access to actual patient data, trial design is based on discussions with expert clinicians

Increased amendments, slower than expected enrolment, costly changes to add new sites and countries, even failed trials

A third of protocol

amendments are avoidable1 ,

at a cost of $0.5m per

amendment.2

How long will the trial take?

Do the inclusion/ exclusion criteria

make sense?

Will we find sufficient

numbers of the right patients?

1. Drug Information Journal, Vol 45, 20112. Industry Standard Research, 2010

Protocol design based on estimates and not optimisedPROTOCOL FEASIBILITY


EHR4CR Protocol Feasibility Services…

Protocol Feasibility Services Central Workbench

PROTOCOL FEASIBILITY


March 2014



…Deployed Across 10 Pilot Sites

Endpoint

Semantics

Orchestrator

Security

Workbench

Registry

PROTOCOL FEASIBILITY


Scenario 2: Patient recruitment

With no searchable patient database, identifying and recruiting suitable patients and trial sites are principal causes of trial delays

Delayed trials increase the burden for sites, waste costly resources and slow access to new drugs

Almost

half of all trial

delays caused by patient recruitment problems2

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

Each day a drug is delayed from market, sponsors lose up to

$8m3

The percentage of studies that complete enrolment on time:

18% in Europe,

7% in the US1

A major cause of trial delayPATIENT RECRUITMENT


March 2014



EHR4CR Patient Recruitment Services…

Site tools to…

Re-use / adapt feasibility query

Identify potential candidates

Contact treating physicians

Evaluate and recruit patients

PATIENT RECRUITMENT

Patient Recruitment Services Local Workbench

Iden

tify Poten

tial Can

didates

Contact

Treating

Physician

s

Evaluate an

d

Recru

it Patien

ts

Man

age

Recruitmen

tAuthorize

Participation /

Grant Access


Scenario 3: Data capture/exchange

The result… Cumbersome and slow processes

Redundant data entry

Transcription inconsistencies

Source issues

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 are entered into the patient’s health record, the clinical trial EDC system, and, possibly, a third paper copy1

Over

70+%of data are perceived by sites as duplicated between EHR and clinical trial systems2

Divided patient care & clinical research information leads to inefficienciesDATA CAPTURE

WORK IN PROGRESS


March 2014



Deliverables

Business Model

Towards Sustainability

1. A self-sustaining economic model

2. A roadmap for pan-European adoption

Technical Platform


Model: A free market ecosystem

An organisation that uses EHR4CR services such as a pharmaceutical company or an academic institution

An organisation that provides EHR4CR services to Service Users

An organisation that contributes data for EHR4CR e.g. hospital

Service User

Service Provider

Data Provider

EHR4CR INSTITUTE

Data aggregation and access services

through standard EHR4CR interfaces

Applications access and deliver

EHR4CR services

DATA PROVIDER

SERVICE PROVIDER

APPLICATION PROVIDERS


SERVICE USER

SERVICE USER

SERVICE USER

NETWORK PROVIDER

DATA PROVIDER

SERVICE PROVIDER



SERVICE PROVIDER



SERVICE PROVIDER



UK DATA ONCOLOGY DATA

PROTOCOL DESIGN &

FEASIBILITY

1 2 3

NETWORK PROVIDERINTERCONNECT


March 2014



Model: Value Propositions

To establish the value

Compare EHR4CR conditions to current practice

Cost-Benefit Assessment (CBA)

InputsVolumes

TimeEffortCost

EHR4CR Services

Efficiency Gains

reduction in the man-time and

costs for protocol feasibility, patient

identification & recruitment, and study conduct

Robust MethodologyMonte Carlo Simulations

GrowthSwift and

scalable market penetration

To forecast business results Balance sheets

revenues minus expenses

Profitability ratio revenues divided by expenses

Business Model Simulation

Profitability and

Sustainability

Validationexperts opinions


Road Map: Seeding the system

At project end there will be

A growing network of data providers

First Service Provider(s)

Committed service users

Institute based in Belgium

Oversight and governance

Specifications

Shared IP

Standards

Certification of systems

Promotion

SERVICE PROVIDER



SERVICE USER

SERVICE USER

DATA PROVIDER A DATA PROVIDER B

EHR4CR INSTITUTE


March 2014



Road Map: Engagement with stakeholders

Stakeholder Engagement Conference in Brussels

April 8th… Satellite event for Pharma

April 9th… Key event with European hospitals

April 10th… Satellite event for potential service providers


Summary: 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

Offering a new paradigm for clinical research in Europe

Clinicalresearcher

Patienthealth records

De-identified data for Clinical

Research


March 2014



Any Questions…

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