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Copy r ight © 2013, SAS Ins t i tu te Inc . A l l r ights reserved.
MANAGING AND ANALYZING CLINICAL DATAMARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS
BIAS MEETING, MARCH 14TH 2014, MILAN, ITALY.
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TABLE OF CONTENTS
• SAS and CDISC• Clinical trial challenges• The promise for CDISC• SAS response• PROC CDISC, SAS Clinical Standards Toolkit, SAS Clinical Data Integration
• Roadmap and SAS destination• Capabilities and processes supported by SAS• Examples
• Roundtrip in define.xml• Reading a define.xml• ADaM support• Bulk metadata manipulation
Copy r ight © 2013, SAS Ins t i tu te Inc . A l l r ights reserved.
BRIDGv1.0
BRIDGv1.1
BRIDGv3.0
BRIDGv2.2
ADaMv2.1
ADaM IGv1.0
BRIDGv1.1.1
BRIDGv2.0
BRIDGv2.1
SDTMv1.2
SDTM IGv3.1.2
CDASHv1.0
ODMv1.1
SDTMv1.0
SDTM IGv3.1
ODMv1.2
BRIDGv3.0.1
BRIDGv3.0.2
BRIDGv3.0.3
ProtocolModelv1.0
ADaM Val.
Checksv1.0
ODMv1.3.1
SDTMv1.1
SDTM IGv3.1.1
ODMv1.2.1
Define.xmlv1.0
ADaMv2.0
ODMv1.3
Pain
Tuberculosis
Devices
BRIDGv3.1
BRIDGv3.2
PRM Toolsetv1.0
CDASH UGv1.0
SDTMv1.3
SDTM IGv3.1.3
ADaMVal. Checks
v1.2
20122006 2007 2009 2011 20132002 201020082005 2003 2004
/
…
Alzheimerv1.0
SENDv3.0
SDTMv3.1.2Am.1
ADaM Val.
Checksv1.1
CDASHv1.1
SDM.XMLv1.0
Parkinson’sDisease
Virology
Content Standards
Technical Standards
Semantics
2014
…
SDTMv1.4
SDTM IGv3.1.4
Alzheimerv1.1
Asthma
SEND v3.0.1
ProtocolConceptGuide
BRIDG UG v2
ADaM IGv1.1
PKD
Define.xml v2.0
CDASH v1.2
BRIDG v4.0
ADaM MD Guide
CDASH E2BSAE IG
SDTM QSSupplements
SDTM Associated Persons IG
v1.0
SDTM Devices IG v1.1
SEND v3.1
ADaM Integration IG
v1.0
ADaM General Occurrence Model
v1.0
SDTM DeviceSubmission Pilot
SDTMv1.5
SDTM IGv3.1.5
SDTM.xml v1.0
CDASH v2.0
Extended ODM PRM XML Schema
Define.xml IG Validation
Multiple Sclerosis
Diabetes
Virology-Hepatitis C
Oncology
Schizophrenia
Therapeutic Brain Injury
CardiovascularTHE CLINICAL TRIAL CHALLENGES
With the growth of industry standards, the level of complexity increases.
The expected trend is continued increase of complexity.
Therapeutic Areas
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CDISC A BUSINESS CASE BY GARTNER AND CDISC
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SAS RESPONSE
• PROC CDISC : SAS first attempt to
support CDISC standards
• SAS Clinical Standards Toolkit
• SAS Clinical Data Integration, SAS
Drug Development
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SAS
CLINICAL RESEARCH INFORMATION FLOW
EDC (Rave)
EDC (Other)Adapters / Interfaces
ePRO and others
Labs and other external sources
Raw data
Internal systems
Metadata, integration and standardization management
SAS Clinical Data Integration
External metadata (RDF, OWL, etc.)
SAS Drug Development
Data and analytics platform
SDTMADaMOthers
Real-world data Raw data
Metadata
Submission data sets
Tables, figures and listings
Pooled analyses
Patient Profiles/ Medical Review
JMP Clinical
SAS Visual
Analytics
Exploration across and beyond trials
Transparency initiatives
Adapters / Interfaces
Adapters / Interfaces
Dictionary coding(TMS)
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PROC CDISC
• Still supported in SAS 9.4, but stable• Support for reading ODM 1.2 and SDTM 3.1• Not flexible enough for custom domains, or for changing standard domains.• No library concept – everything built-in in code• Advise against deployment and replace by novel SAS technologies
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SAS CST SAS CLINICAL STANDARDS TOOLKIT
• The SAS Clinical Standards Toolkit (SAS CST) provides SAS implementation
of evolving clinical standards and provide a framework that exploits these
standards to meet common clinical research analysis and submission
requirements. • SAS CST provides support both for CDISC and non-CDISC general clinical
standards• Support for SAS table and XML files• Some Java and XLST inside to manage XML files.• SAS Clinical Standards Toolkit 1.6 : released February 2014 based on SAS
9.4
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SAS CDI SAS CLINICAL DATA INTEGRATION
• Is targeted for both SAS programmers and clinical data managers• SAS Clinical Standards Toolkit “under the hood”• SAS Clinical Data Integration capabilities now integrated in SAS Drug
Development with code that is generated in SAS CDI can be executed
straight from SAS Drug Development
SAS Clinical Data Integration is a data transformation solution designed to help companies organize, standardize and manage their clinical research data and metadata. The solution enables companies to
Integrate data from disparate sourcesIntegration with EDC systems, e.g. Medidata RaveStandardize their in-process data to industry modelsMigrate legacy data to modern standard modelsLeverage standardized data to efficiently prepare data for analysis and submission to regulatory authorities.
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SAS Life Science Analytics Framework
Data Capture to Data Analysis
CONVERSION
Compound Info Life Cycle
REPOSITORY
Detailed Data Store,
Metadata Store
Data Quality Service
Protocol Design
EDC/CDMS
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SAS LIFE SCIENCE ANALYTICS
FRAMEWORKA NEW FRAMEWORK FOR CLINICAL TRIAL ANALYTICS
Analysis & Regulatory
Controls
Workflow
Compliance
Analysis processes
Process traceability
Data Standards Repository
Study & standards metadata
Import/export metadata
Connects protocol/study
design
Manage controlled
terminology
Information Management
Mapping
Instance data standards
Integration (EDC, Safety, ePRO, etc.)
Data traceability/
lineage
Operations & Optimization
Risk based scoring and monitoring
Post marketing &
safety surveillance
Site selection/ management
Patient recruitment
Other SAS Offerings
Visual Analytics
Data Transparency
Enterprise Miner
others
Primary Platform• Shared repository• Single identity• Partner collaboration
• Licensing• Hosting model• Access & audit trail
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SAS & CDISC END-TO-END IN CDISC
Data models
Validation / Adherence
checks
SAS code generation
Macro API library and
customization
Metadata
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SAS & CDISC END-TO-END IN CDISC : SAS CST 1.6 AND SAS CDI 2.5
SDTM up to 3.2 (SDTM
1.4 IG)
SAS Clinical Data
Integration
SAS Clinical
Standards Toolkit
ODM 1.3.1support
Validate Toolkit
metadata
SDTM up to 3.2 (SDTM 3.1.4 IG)
Extract Clinical and Reference
data into SAS datasets
CRT-DDS 1.0 support
Import and export
define.xml files
ADaM support 2.1
updates
SEND 3.0 standard support
Controlled terminology
support
Full UTF-8 and S-JIS
code support
Updates to macro
framework
Define-XML 2.0 support
Import ADaM, SDTM and SEND
information from define.xml
Code runs everywhere
Incremental and granular
standards update in SAS
CDI
Custom domain promotion and
standards governance
Integration with
Medidata Rave / EDC
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DEFINE.XML ROUND TRIP
Sponsor•Creates define.xml based on study specifications
Data Management Team(CRO)•Extracts metadata from define.xml file
Data Management Team(CRO)• Implements and populates domains
Data Management Team(CRO)•Produces define.xml based on implementation
Sponsor•Extracts metadata from implemented define.xml file
Sponsor•Compares results to study specifications
DEFINE.XML
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%crtdds_read%sdtmutil_create Src Meta From
CRTDDS
%cstutil_create Tables From
Metadata
%sdtmutil_ Create Formats From
CRTDDS
READING THE DEFINE.XML
SAS representation of CRT-DDS
Code List SAS Format Catalog
zero observation Domain data sets
Source_*.sas7bdat
DEFINE.XML
SAS CLINICAL STANDARDS TOOLKIT
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READING THEDEFINE.XML
SAS CLINICAL DATA INTEGRATION
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CDI 2.4
ADAM SUPPORT
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CDI 2.4
BULK METADATA MANIPULATION
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GOAL
• SAS provides you with a complete technology and solution framework, not
just to use CDISC standards, but to manage and generate clinical standards
data with the aim to visualize, analyze, submit, and ensure high quality-
clinical data
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VISUALIZATION