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Data Challenges in Clinical Research
Chris Roche, CEO, Aridhia
Chris Roche, CEO, Aridhia
Today’s speaker
Chris joined Aridhia in 2014 to provide strategic commercial leadership
as Aridhia embraced new 3rd generation technologies to support their
new cloud based business model and collaborative data science
platform. Chris combines a background in computing, specialising in
artificial intelligence and business transformation. He spent 14 years at
EMC, where he held a number of senior director positions including
serving as Country Manager for EMC in Ireland, Regional Director for
Greenplum, EMC’s Big Data business and as EMEA CTO. He holds a
1st Class Degree in Computing and Information Technology (BScHons),
is a member of the British Computer Society (MBCS) and is qualified as
a Chartered Engineer (CEng) and Chartered Information Technology
Practitioner (CITP).
Data Challenges in Clinical Research
Today’s agenda
o Introduction to Clinical Research & Data
o Market Challenges and the Aridhia Business Model
o Data in Clinical Research Use Cases
o Aridhia Business Transformation Journey
o Data, Technology and Roadmap
o Q&A
4
Increasing productivity in the collaborative research workflow
Data
discovery
Data capture
Data load
Data quality
Analysis
Visualisation
Data analyst / Data owner /
Biostatistician / Researcher
Data owner
Data analyst /
Biostatistician / CRO
Data steward and analyst
/ Biostatistician / Pharma
End user
(clinician, manager, MDT,
patient, etc.)
Statistician / Data analyst /
Biostatistician and domain
expert etc.
Distribute output
Integrating precision medicine into the workflow
Data
discovery
Data capture
Data load
Data quality
Analysis
Visualisation
Data analyst / Data owner /
Biostatistician / Researcher
Data owner
Data analyst /
Biostatistician / CRO
Data steward and analyst
/ Biostatistician / Pharma
End user
(clinician, manager, MDT,
patient, etc.)
Statistician / Data analyst /
Biostatistician and domain
expert etc.
Distribute output
Operational healthcare
Multidisciplinary team meeting Risk prediction Population health
Collaborative R&D
projects
Pre-competitive
consortia
Research institutions/
ecosystems Diagnostics
Use cases
INDUSTRIALISATION GOVERNANCE REPRODUCIBILITY SERVICERAPID PROTOTYPING
What slows the process?
The status quo is not an option:
current data capability is unable to cope
A new approach is required
Change the way research and PM interacts with their data
ACRIS – Advanced Clinical Research Information Systems
ACRIS:
• a complex constellation of capabilities
that can rapidly assemble data assets
for clinical research questions
Provides:
• data mining and research process
support to meet the needs of clinical
and translational research
• related biostatistics and biocomputation
Includes:
• electronic health record (EHR) access
• open-source components
• an approach for big data needs
International hubs
NetherlandsUK
Team
DevOps and
Service Delivery
Enablement
Innovation
Business Operations
Glasgow / Edinburgh
EPAD – Alzheimer's Dementia adaptive clinical trial
• Traumatic Brain Injury (TBI) is a leading worldwide problem; the annual incidence of
hospitalisation following TBI ranges from 108-332 new cases per 100,000 inhabitants
• 72 million time points of data per patient stay (mean stay 2 days)
• 1.6Gb of data per patient per day, approximately 1.5Mb of data per minute per patient
• Near real-time integration of high-frequency ICU data, research & implement physiological
models & delivery of results back to the bedside
• Developing tools that can predict disease activity over a 12-month horizon for adults
recently diagnosed with relapsing-onset multiple sclerosis (MS)
• Patient reported outcomes, clinical, genomic analysis and quantitative neuroimaging data
will be evaluated to determine the optimum predictive tool, enabling NHS clinicians to
map a personalised trajectory of disease and predict those patients with a high likelihood
of transitioning to secondary progressive MS
• Will enable early intervention and result in focused delivery of the finite disease modifying
treatment drug budget to patients with the most compelling basis to receive treatment
• Data capture to deliver real-time NHS data integration across 4 NHS boards
“Radboud university medical center is a leading academic center for patient care, education and
research, with the mission ‘to have a significant impact on healthcare’.
Our activities help to improve healthcare and consequently the health of individuals and of society.
We believe we can achieve that by providing excellent quality, participatory and personalized
healthcare, operational excellence and by working together in sustainable networks.”
‘From bricks to clicks’
Education
Digital Learning
Environment (DLE)
Care
Electronic Medical
Record (EMR)
Research
Digital Research
Environment (DRE)
Business transformation
Revenue Enablement DevOps
Secure FTP
Flat files, XML,
unstructured Virtual DesktopWeb Access
Security and Identity Management
App User / Member Data Scientist Administrator
CollaborativeWorkspaceUserInterface
Secure Messaging
HL, FHIR, other
payload
Active
Database agent
Direct EHR
connection
Active Web
service agent
FHIR, Web Services
HealthcareLandingZone
Services
Apps
Collaborative Services
Audit
Analytical Tools
Data and Compute Fabric
Admin
N3
Connection
Repository
e.g. Genomic store
Hadoop
Workspace DB
Health Analytics
Schema (option)
Workspace DB
MGRID HL7 RIM
Schema
(roadmap)
Workspace DB
Schema-agnostic
data lake
Web Access
SQL, R, R Shiny,
MADLIB
Virtual Desktop
Bring your
own tools
Collaboration
Tagging,
messaging,
notification,
alerts
Audit
Access, usage,
authentication,
provisioning,
upload
Apps
User-built analytical apps and output
or Aridhia-populated apps
e.g. LaTEX publishing, Health Analytic
Schema, data quality…
De-identification Service
Table Mapping
Dataset Library
Health Analytics Schema
Ontology Service
Direct to File Store
Data Quality Reports Data Linkage Reports Data Selection API
Data Staging Network Security App Hosting
Healthcare Landing Zone
Precision Medicine PaaS
Multi-site LIMS
Sample
Management
CTM
System
DICOM
End-Point
BIX Workflow
Data Asset
Repository
Federated Analysis API
Life-Cycle
Container
Secure file share
Large unstructured
Precision Medicine
Workspace
Small Clinical Trials
Workspace
Healthcare Landing Zone Workspaces
Key Management
Database
De-identification
Service
Data Preparation
Airlock
CDR
Workspace
Data Export
Participant Privacy
Management
Core Services
Client-specific Services
Available for Subsequent Research Use
Dynamic Consent
Dataset Library
Service
Ontology Service
Health Analytics
Schema
App Hosting Area
(Analytics application/
local applications)
Data Modelling and
Compliance
Financial
& Admin
Research &
Non-clinical
Data
Research
External
Database
Care Domain
(Client)
PACS
(if
required)
EPRS &
Clinical
EPRS Direct
PACS Direct
Custom Reports
Shared Care
Portal
Archiving
Healthcare Landing Zone
(* = roadmap 2016)
Benefits - impact on common research tasks
Research task Tools provided Time to Value
Sourcing data Connectivity with NHS sites Weeks
Castor GCP-level EDC (partner service) Days
De-identification De-identification Service <24h
Upload SFTP, tabular data mapping Minutes
Data Quality Data quality report, Ontology Service, Dataset Library Service <3h
Linkage Consistent study IDs, data model support, omics templates* Hours
Visualisation Quick visualisation tools On demand
Exploratory Analytics R, SQL + MADLIB On demand
Feature extraction Bioinformatics, image analysis toolkits On demand
Training models MADLIB, Python, Spark*, parallel computing Hours
Common analysis R packages (e.g. Survival), 3rd party tools Hours
Publication Publication quality PDF, PowerPoint <6h
App prototyping Shiny mini-apps 1-2 days
Roadmap – integrated vision for clinical informatics
Collaboration
Participant
Privacy &
Consent
Precision
Medicine
Workflows
Federated
Analysis
AnalyticsHealthcare
Landing
Zone
Hospital Integrations Transactions per patientResearch & Innovation Projects
Ontology
Service
Specialty
Apps
Data
Catalogue
Electronic
Data
Capture
28
Questions?
http://pivotal.io/resources
https://blog.pivotal.io/
29
Resources
https://springoneplatform.io/
30
Resources
http://www.aridhia.com/services/analytixagility-project-edition/
http://www.aridhia.com/services/analytixagility-ecosystem-edition/
http://www.aridhia.com/resources/library/
Challenges in Clinical Research: Aridhia Disrupts Technology Approach to Research Analytics

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Challenges in Clinical Research: Aridhia Disrupts Technology Approach to Research Analytics

  • 1. Data Challenges in Clinical Research Chris Roche, CEO, Aridhia
  • 2. Chris Roche, CEO, Aridhia Today’s speaker Chris joined Aridhia in 2014 to provide strategic commercial leadership as Aridhia embraced new 3rd generation technologies to support their new cloud based business model and collaborative data science platform. Chris combines a background in computing, specialising in artificial intelligence and business transformation. He spent 14 years at EMC, where he held a number of senior director positions including serving as Country Manager for EMC in Ireland, Regional Director for Greenplum, EMC’s Big Data business and as EMEA CTO. He holds a 1st Class Degree in Computing and Information Technology (BScHons), is a member of the British Computer Society (MBCS) and is qualified as a Chartered Engineer (CEng) and Chartered Information Technology Practitioner (CITP).
  • 3. Data Challenges in Clinical Research Today’s agenda o Introduction to Clinical Research & Data o Market Challenges and the Aridhia Business Model o Data in Clinical Research Use Cases o Aridhia Business Transformation Journey o Data, Technology and Roadmap o Q&A
  • 4. 4
  • 5.
  • 6. Increasing productivity in the collaborative research workflow Data discovery Data capture Data load Data quality Analysis Visualisation Data analyst / Data owner / Biostatistician / Researcher Data owner Data analyst / Biostatistician / CRO Data steward and analyst / Biostatistician / Pharma End user (clinician, manager, MDT, patient, etc.) Statistician / Data analyst / Biostatistician and domain expert etc. Distribute output
  • 7. Integrating precision medicine into the workflow Data discovery Data capture Data load Data quality Analysis Visualisation Data analyst / Data owner / Biostatistician / Researcher Data owner Data analyst / Biostatistician / CRO Data steward and analyst / Biostatistician / Pharma End user (clinician, manager, MDT, patient, etc.) Statistician / Data analyst / Biostatistician and domain expert etc. Distribute output
  • 8. Operational healthcare Multidisciplinary team meeting Risk prediction Population health
  • 10. INDUSTRIALISATION GOVERNANCE REPRODUCIBILITY SERVICERAPID PROTOTYPING What slows the process?
  • 11. The status quo is not an option: current data capability is unable to cope
  • 12. A new approach is required
  • 13. Change the way research and PM interacts with their data
  • 14. ACRIS – Advanced Clinical Research Information Systems ACRIS: • a complex constellation of capabilities that can rapidly assemble data assets for clinical research questions Provides: • data mining and research process support to meet the needs of clinical and translational research • related biostatistics and biocomputation Includes: • electronic health record (EHR) access • open-source components • an approach for big data needs
  • 17. EPAD – Alzheimer's Dementia adaptive clinical trial
  • 18. • Traumatic Brain Injury (TBI) is a leading worldwide problem; the annual incidence of hospitalisation following TBI ranges from 108-332 new cases per 100,000 inhabitants • 72 million time points of data per patient stay (mean stay 2 days) • 1.6Gb of data per patient per day, approximately 1.5Mb of data per minute per patient • Near real-time integration of high-frequency ICU data, research & implement physiological models & delivery of results back to the bedside
  • 19. • Developing tools that can predict disease activity over a 12-month horizon for adults recently diagnosed with relapsing-onset multiple sclerosis (MS) • Patient reported outcomes, clinical, genomic analysis and quantitative neuroimaging data will be evaluated to determine the optimum predictive tool, enabling NHS clinicians to map a personalised trajectory of disease and predict those patients with a high likelihood of transitioning to secondary progressive MS • Will enable early intervention and result in focused delivery of the finite disease modifying treatment drug budget to patients with the most compelling basis to receive treatment • Data capture to deliver real-time NHS data integration across 4 NHS boards
  • 20.
  • 21. “Radboud university medical center is a leading academic center for patient care, education and research, with the mission ‘to have a significant impact on healthcare’. Our activities help to improve healthcare and consequently the health of individuals and of society. We believe we can achieve that by providing excellent quality, participatory and personalized healthcare, operational excellence and by working together in sustainable networks.”
  • 22. ‘From bricks to clicks’ Education Digital Learning Environment (DLE) Care Electronic Medical Record (EMR) Research Digital Research Environment (DRE)
  • 24. Secure FTP Flat files, XML, unstructured Virtual DesktopWeb Access Security and Identity Management App User / Member Data Scientist Administrator CollaborativeWorkspaceUserInterface Secure Messaging HL, FHIR, other payload Active Database agent Direct EHR connection Active Web service agent FHIR, Web Services HealthcareLandingZone Services Apps Collaborative Services Audit Analytical Tools Data and Compute Fabric Admin N3 Connection Repository e.g. Genomic store Hadoop Workspace DB Health Analytics Schema (option) Workspace DB MGRID HL7 RIM Schema (roadmap) Workspace DB Schema-agnostic data lake Web Access SQL, R, R Shiny, MADLIB Virtual Desktop Bring your own tools Collaboration Tagging, messaging, notification, alerts Audit Access, usage, authentication, provisioning, upload Apps User-built analytical apps and output or Aridhia-populated apps e.g. LaTEX publishing, Health Analytic Schema, data quality… De-identification Service Table Mapping Dataset Library Health Analytics Schema Ontology Service Direct to File Store Data Quality Reports Data Linkage Reports Data Selection API Data Staging Network Security App Hosting Healthcare Landing Zone Precision Medicine PaaS Multi-site LIMS Sample Management CTM System DICOM End-Point BIX Workflow Data Asset Repository Federated Analysis API Life-Cycle Container Secure file share Large unstructured
  • 25. Precision Medicine Workspace Small Clinical Trials Workspace Healthcare Landing Zone Workspaces Key Management Database De-identification Service Data Preparation Airlock CDR Workspace Data Export Participant Privacy Management Core Services Client-specific Services Available for Subsequent Research Use Dynamic Consent Dataset Library Service Ontology Service Health Analytics Schema App Hosting Area (Analytics application/ local applications) Data Modelling and Compliance Financial & Admin Research & Non-clinical Data Research External Database Care Domain (Client) PACS (if required) EPRS & Clinical EPRS Direct PACS Direct Custom Reports Shared Care Portal Archiving Healthcare Landing Zone
  • 26. (* = roadmap 2016) Benefits - impact on common research tasks Research task Tools provided Time to Value Sourcing data Connectivity with NHS sites Weeks Castor GCP-level EDC (partner service) Days De-identification De-identification Service <24h Upload SFTP, tabular data mapping Minutes Data Quality Data quality report, Ontology Service, Dataset Library Service <3h Linkage Consistent study IDs, data model support, omics templates* Hours Visualisation Quick visualisation tools On demand Exploratory Analytics R, SQL + MADLIB On demand Feature extraction Bioinformatics, image analysis toolkits On demand Training models MADLIB, Python, Spark*, parallel computing Hours Common analysis R packages (e.g. Survival), 3rd party tools Hours Publication Publication quality PDF, PowerPoint <6h App prototyping Shiny mini-apps 1-2 days
  • 27. Roadmap – integrated vision for clinical informatics Collaboration Participant Privacy & Consent Precision Medicine Workflows Federated Analysis AnalyticsHealthcare Landing Zone Hospital Integrations Transactions per patientResearch & Innovation Projects Ontology Service Specialty Apps Data Catalogue Electronic Data Capture