Enabling clinical research in West Midlands:
ePCRN, TRANSFoRm and CuRE projects
Theodoros N. Arvanitis, RT, DPhil, CEng, MIET, MIEEE, AMIA, FSIM, FRSM
Professor of e-Health Innovation
Institute of Digital Healthcare, WMG, University of Warwick
Birmingham Children’s Hospital NHS Foundation Trust
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Professor T.N. Arvanitis - 13/12/2013
Slide 1
translating research into clinical practice
• Development of Clinical Trial Management Systems
that provide, through an integrated infrastructure, a
wide-ranging set of modular, interoperable and
standards based tools designed to meet the needs of
clinical trials
• Objectives of e-trials system implementation
– To define a “computable” model representation that
supports the entire life-cycle of clinical trials protocol,
– To develop appropriate tools that use the model
representation.
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Slide 2
Clinical trials life-cycle
Adapted from Source: Douglas Fridsma, MD, PhD
The University of Pittsburgh Cancer Institute Centre for
Pathology and Oncology Informatics Clinical Trials
Research Core
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Professor T.N. Arvanitis - 13/12/2013
Slide 3
Learning Healthcare System
Safer Clinical
Practice
Knowledge
Translation
Software
• Integration
• Interoperability
• Services
Epidemiological
Studies & RCTs
More research
evidence
B. C. Delaney, K. A. Peterson, S. Speedie, A. Taweel, T. N. Arvanitis and F. D. R. Hobbs,
Envisioning a Learning Health Care System: The Electronic Primary Care Research Network, A Case Study,
Annals of Family Medicine, 10(1):54-59, 2012.
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Professor T.N. Arvanitis - 13/12/2013
Slide 4
electronic Primary Care Research Network
•
•
•
The electronic Primary Care Research Network (ePCRN) was an NIH Roadmap
funded project designed to explore the feasibility of conducting clinical trials in
the community– specifically in primary care settings.
The ePCRN electronically links a variety of primary care practices and facilitates
secure communication with those practices thereby protecting the privacy and
confidentiality of the patient.
There are three primary components to the ePCRN:
1.
a trialist workbench for designing clinical trials
2.
a clinical trials’ management component for conducting and managing
clinical research studies.
3.
Tools for translating research into practice
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Professor T.N. Arvanitis - 13/12/2013
Slide 5
ePCRN: US/UK perspective
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Slide 6
ePCRN Study and eCRF tools
Protocol
Timeline
CRFs
Design
Study
Study
Database
Collect
Data
Analyse
Data
The following provide some example screenshots of
the eCRF technology on a current ePCRN prototype
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Slide 7
Protocol Design
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Slide 8
Timeline Design
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Slide 9
eCRF Design
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Slide 10
Acknowledgments for ePCRN
Re-Engineering the Clinical Research Enterprise
ePCRN Contract No. HHSN268200425212C
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Slide 11
knowledge in healthcare
Specific
research
knowledge
•
•
•
•
EHR systems
Wide coverage
Vast quantity
May lack in detail
and quality
•
•
•
Clinical trials
Controlled populations
Well-defined questions
•
Routinely
collected
knowledge
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Actionable
knowledge
•
•
Distilled scientific
findings
Usable in clinical
practice
Decision support
Slide 12
Informatics tower of Babel:
the grand challenge
• Overwhelming volume of data
• Multitude of sources
• Each part of the health community
speaks its own scientific “dialect”
(e.g. lab values, genetic profile,
clinical data)
• Lack of consensus on common
standards and terms
• Lack of coordination across, and
collaboration within, the cancer
research enterprise
• Integration is critical to achieve
promise of molecular medicine
(personalised medicine)
Slide courtesy of caBIG™
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Professor T.N. Arvanitis - 13/12/2013
Slide 13
TRANSFoRm Itegrated VS
• The TRANSFoRm Integrated Vocabulary
Service is designed to allow end users to
search and retrieve clinical vocabulary concepts
and associated content
– a web interface and a web service API
– the service uses the LexEVS (version 5.1 and
version 6.0) technology to access a backend UMLS
vocabulary database
– the service uses direct Java Database Connectivity
(JDBC) to access other vocabulary databases (e.g.
Read Codes V2, ICPC2)
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Slide 14
A screenshot of the vocabulary
service web-based interface
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Slide 15
Example eligibility criterion
• HbA1c test result of ≥ 6.5% on or before the
16/04/2013.
–
–
–
–
laboratory_Test_Type_ID=[LOINC;4548-4]
laboratory_measurement_datum ≥ 6.5
laboratory_measurement_unit_label = [UO;0000187]
lab_result_confirmation_instant ≤ 2013/04/16
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Slide 16
TRANSFoRm Query Workbench
Identifying
Identifying
prevalent
prevalent
cases
cases
through
through
eligible
eligible
counts
counts
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Slide 17
acknowledgments: TRANSFoRm
Consortium
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Slide 18
CURe
CURe (Comprehensive Unified Research) is a framework for the
development of software systems for research.
It has been developed to create extensible research systems for various
medical conditions.
Common data elements to all medical areas, as well as specialist
requirements can be handled by the framework.
Example user interface
for selecting medication
medications use the
dictionary of medicines and
devices (dm+d).
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Slide 19
Acknowledgments for CURe
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Slide 20
realising our imagination: facing challenges
"Leave the beaten track occasionally and dive into the
woods. Every time you do so, you will be certain to
find something that you have never seen before.
Follow it up, explore all around it, and before you
know it, you will have something worth thinking
about to occupy your mind. All really big discoveries
are the result of thought."
Alexander Graham Bell: "electrical
speech machine" of 1876
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Slide 21
Thank you
t.arvanitis@warwick.ac.uk
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Slide 22