END-TO-END DATA AND METADATA: IT'S NOT ONLY A DREAM, IT'S A REALITY
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© Confidential | 00 mois 2013 | Nom de la présentation | Auteur 1
A VISION : ADOPT AN END-TO-END PROCESS FROM THE PROTOCOL TO THE CSR 01
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© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 2
STATE OF THE ART
From Prehistoric ages to Clinical Standardised Digitalisation
Data Visualisation Needs
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Old Process • Paper CRF • Outsourcing • Low number of standards
New Process • Electronic CRF • 100% CDISC compliant Tools in an End-to-End process
• Ease Data Visualization and Exploitation
Digitalisation • Electronic PRO based on Smartphone application
• Medical Devices • Connected objects data capture
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
Support for Data Review Meeting based on Clinical Data
Study Metadata exploitation
Monitor Clinical Operations (Enrollment Curve, SDV, Data Entry, Queries, …)
Data Management Metrics (Time to Data Entry, Number of queries per subject, Data change, …)
More it is big, more it is important
End-to-EndMetadata
Seman
-callyIn
terope
rableMetad
ataDriven
ProtocolConceptsandAssessments ADaMCDASH SDTM Endpoints&
AnalysisResultsDataCollec-on
Modules
STAN
DARD
S
LIBR
ARY
CLINICAL STUDY DATA LIFECYCLE
EDCSetup Genera-on AnalysisConversion
AUTO
MAT
ION
&VAL
IDAT
ION
CRF
Endpoints&AnalysisResults
CDASH ADaMSDTM
Protocol TrialDesign
STUDY
METAD
ATA
REPO
SITO
RY
© Business & Decision Life Sciences 2016 All rights reserved. Author : Peter Van Reusel
AnalysisResults
PLAN
NING&
REPO
RTING
DataManagement
Sta-s-calProgramming
ClinicalStudyReport
ClinicalDevelopment
Plan
Source SDTM ADaM TFLs
Submission
PROCE
SS&
DATA
Protocol
DataCollec-on
Sta-s-calAnalysisPlan
document
data
SAPAuthoring
Protocol&TrialDesignAuthoring
CSRAuthoring
AUTH
ORING
metad
ata
StudyDesignConfigura-on
StudySetup
AnalysisPlanning
SPEC
IFICAT
ION&
CONFIGURA
TION
ONCE UPON A TIME… A CLINICAL STUDY THROUGH DATA VISUALISATION 02
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© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 5
DANONE CLINICAL DATA FLOW (DANFLOW)
ODMODMw/DATACRFMetadataRepository
Formedix ORIGINS®
Func
tion
Tool
s
Physical Exam
Adverse Events
Con Meds.
DataRepository
Medidata RAVE ® OpenClinica
SDTM
SAS.xpt
EDCETL
Define.xml
XML4Pharma SDTM ETL ® File Server
Task
CRF Design Data Collection and Processing Data Mapping Data Storage
ETL
EDC Independent Study doc.generation
Speed up Build
Ben
efits
Best ratio : Study Needs / Cost saving
Automate SDTM Mapping User friendly – Drag & Drop
Ease data pooling Data Visualization Data Warehousing
CDASH Standards
Adopt a compatible ePRO solution
SDTM Standards
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
DATA Repository
Study Metadata
Operational Metadata
Metadata Catalog
Visualization
Study documents
DATA
DATA PREPARATION FOR VISUALISATION
Study documents capture
Clinical DATA Pooling Clinical Data
Warehouse
Trial Design Tables
SDTM Tables AdAM Tables
Assessments Interventions Findings
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
DM METRICS AND CLINICAL DASHBOARDS (ONGOING)
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EDCETL
Visualization ODM
Web
Services
Ensure up-to-date data
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
DATA VISUALISATION SOME EXAMPLES 03
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© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 9
METADATA CATALOG VISUALISATION GLOBAL OVERVIEW
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
METADATA CATALOG VISUALISATION STUDY ID CARD
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
CLINICAL DATA VISUALISATION ENROLLMENT CURVE PER VISIT – DROP OUT
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
CLINICAL DATA VISUALISATION SUBJECT RECRUITMENT PER WEEK
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
RETURN-ON-EXPERIENCE 04 00 mois 0000
© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 14
USE CASES & BENEFITS
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Metadata Catalog
Trial Design Tables
EDC
Clinical Data Warehouse
SDTM Tables AdAM Tables
Visualization Raw and Analysis data capitalisation Data Review meeting support Cross study Data Exploitation
Clinical study results
Scientists : Establish new Clinical development plan for future products Manager : Have an overview on KPI from all past studies Biostatistician : Help to build statistical plan for Meta-analysis
Clinical operations monitoring Data Management metrics
Risk Based Monitoring
…a clinical study
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU
RETURN-ON-EXPERIENCE
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Mandatory to use an End-to-End process integrally based on CDISC Standards for
Data, Metadata and Data Management tools.
Retrieve efficiently and easily all data & information from the protocol to the CSR ensuring a continuous workflow among Clinical Core team members
Importance to use a Agile methodology based on Use Cases/User Stories to create visualisation for each
business needs and exploit efficiently data & information for each user profile
© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU