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Copyright © 2013, SAS Institute Inc. All rights reserved. MANAGING AND ANALYZING CLINICAL DATA MARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS BIAS.

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Presentation on theme: "Copyright © 2013, SAS Institute Inc. All rights reserved. MANAGING AND ANALYZING CLINICAL DATA MARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS BIAS."— Presentation transcript:

1 Copyright © 2013, SAS Institute Inc. All rights reserved. MANAGING AND ANALYZING CLINICAL DATA MARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS BIAS MEETING, MARCH 14 TH 2014, MILAN, ITALY.

2 Copyright © 2013, SAS Institute Inc. All rights reserved. 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

3 Copyright © 2013, SAS Institute Inc. All rights reserved. BRIDG v1.0 BRIDG v1.1 BRIDG v3.0 BRIDG v2.2 ADaM v2.1 ADaM IG v1.0 BRIDG v1.1.1 BRIDG v2.0 BRIDG v2.1 SDTM v1.2 SDTM IG v3.1.2 CDASH v1.0 ODM v1.1 SDTM v1.0 SDTM IG v3.1 ODM v1.2 BRIDG v3.0.1 BRIDG v3.0.2 BRIDG v3.0.3 Protocol Model v1.0 ADaM Val. Checks v1.0 ODM v1.3.1 SDTM v1.1 SDTM IG v3.1.1 ODM v1.2.1 Define.xml v1.0 ADaM v2.0 ODM v1.3 Pain Tuberculosis Devices BRIDG v3.1 BRIDG v3.2 PRM Toolset v1.0 CDASH UG v1.0 SDTM v1.3 SDTM IG v3.1.3 ADaM Val. Checks v1.2 2012200620072009 2011 2013 200220102008200520032004 / … Alzheimer v1.0 SEND v3.0 SDTM v3.1.2 Am.1 ADaM Val. Checks v1.1 CDASH v1.1 SDM.XML v1.0 Parkinson’s Disease Virology Content Standards Technical Standards Semantics 2014 … SDTM v1.4 SDTM IG v3.1.4 Alzheimer v1.1 Asthma SEND v3.0.1 Protocol Concept Guide BRIDG UG v2 ADaM IG v1.1 PKD Define.xml v2.0 CDASH v1.2 BRIDG v4.0 ADaM MD Guide CDASH E2B SAE IG SDTM QS Supplements 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 Device Submission Pilot SDTM v1.5 SDTM IG v3.1.5 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 Cardiovascular THE CLINICAL TRIAL CHALLENGES With the growth of industry standards, the level of complexity increases. The expected trend is continued increase of complexity. Therapeutic Areas

4 Copyright © 2013, SAS Institute Inc. All rights reserved. CDISC A BUSINESS CASE BY GARTNER AND CDISC

5 Copyright © 2013, SAS Institute Inc. All rights reserved. SAS RESPONSE PROC CDISC : SAS first attempt to support CDISC standards SAS Clinical Standards Toolkit SAS Clinical Data Integration, SAS Drug Development

6 Copyright © 2013, SAS Institute Inc. All rights reserved. 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 SDTM ADaM Others 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 Dictionary coding (TMS)

7 Copyright © 2013, SAS Institute Inc. All rights reserved. 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

8 Copyright © 2013, SAS Institute Inc. All rights reserved. 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

9 Copyright © 2013, SAS Institute Inc. All rights reserved. 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 sources Integration with EDC systems, e.g. Medidata Rave Standardize their in-process data to industry models Migrate legacy data to modern standard models Leverage standardized data to efficiently prepare data for analysis and submission to regulatory authorities. 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 sources Integration with EDC systems, e.g. Medidata Rave Standardize their in-process data to industry models Migrate legacy data to modern standard models Leverage standardized data to efficiently prepare data for analysis and submission to regulatory authorities.

10 Copyright © 2013, SAS Institute Inc. All rights reserved. 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

11 Copyright © 2013, SAS Institute Inc. All rights reserved. SAS LIFE SCIENCE ANALYTICS FRAMEWORK A NEW FRAMEWORK FOR CLINICAL TRIAL ANALYTICS Analysis & Regulatory Controls WorkflowCompliance 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 Primary Platform Shared repository Single identity Partner collaboration Licensing Hosting model Access & audit trail

12 Copyright © 2013, SAS Institute Inc. All rights reserved. SAS & CDISC END-TO-END IN CDISC Data models Validation / Adherence checks SAS code generation Macro API library and customization Metadata

13 Copyright © 2013, SAS Institute Inc. All rights reserved. SAS & CDISC END-TO-END IN CDISC : SAS CST 1.6 AND SAS CDI 2.5

14 Copyright © 2013, SAS Institute Inc. All rights reserved. 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

15 Copyright © 2013, SAS Institute Inc. All rights reserved. %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

16 Copyright © 2013, SAS Institute Inc. All rights reserved. READING THE DEFINE.XML SAS CLINICAL DATA INTEGRATION

17 Copyright © 2013, SAS Institute Inc. All rights reserved. CDI 2.4 ADAM SUPPORT

18 Copyright © 2013, SAS Institute Inc. All rights reserved. CDI 2.4 BULK METADATA MANIPULATION

19 Copyright © 2013, SAS Institute Inc. All rights reserved. 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

20 Copyright © 2013, SAS Institute Inc. All rights reserved. VISUALIZATION


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