Data Challenges in Clinical Research Chris Roche, CEO, Aridhia

Chris Roche, CEO, AridhiaToday’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 ResearchToday’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

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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

Netherlands UK

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 FTPFlat files, XML, unstructured Virtual DesktopWeb Access

Security and Identity Management

App User / Member Data Scientist Administrator

Col

labo

rativ

e W

orks

pace

Use

r Int

erfa

ce

Secure MessagingHL, FHIR, other

payload

Active Database agent

Direct EHR connection

Active Web service agent

FHIR, Web Services

Hea

lthca

re L

andi

ng Z

one

Ser

vice

s

Apps

Collaborative Services

Audit

Analytical Tools

Data and Compute Fabric

Admin

N3 Connection

Repositorye.g. Genomic store

Hadoop

Workspace DBHealth Analytics Schema (option)

Workspace DBMGRID HL7 RIM

Schema(roadmap)

Workspace DBSchema-agnostic

data lake

Web AccessSQL, R, R Shiny,

MADLIB

Virtual DesktopBring your own tools

CollaborationTagging,

messaging, notification,

alerts

AuditAccess, usage, authentication, provisioning,

upload

AppsUser-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

CTMSystem

DICOM End-Point BIX Workflow

Data Asset Repository

Federated Analysis API

Life-Cycle Container

Secure file shareLarge unstructured

Precision Medicine Workspace

Small Clinical Trials Workspace

Healthcare Landing Zone Workspaces

Key Management Database

De-identificationService

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 ReportsShared Care Portal

Archiving

Healthcare Landing Zone

(* = roadmap 2016)

Benefits - impact on common research tasksResearch 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

CollaborationParticipantPrivacy &Consent

Precision Medicine

Workflows

FederatedAnalysis

AnalyticsHealthcareLanding

Zone

Hospital Integrations Transactions per patientResearch & Innovation Projects

OntologyService

SpecialtyApps

Data Catalogue

ElectronicData

Capture

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Questions?

http://pivotal.io/resourceshttps://blog.pivotal.io/

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Resources

https://springoneplatform.io/

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Resources

http://www.aridhia.com/services/analytixagility-project-edition/http://www.aridhia.com/services/analytixagility-ecosystem-edition/

http://www.aridhia.com/resources/library/