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Managing and Analyzing Clinical Data

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Presentation on theme: "Managing and Analyzing Clinical Data"— Presentation transcript:

1 Managing and Analyzing Clinical Data
Mark Lambrecht, Principal Industry Consultant, SAS BIAS Meeting, March 14th 2014, Milan, Italy.

2 Roadmap and SAS destination
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 The clinical trial challenges
SDTM Devices IG v1.1 SEND v3.1 ADaM Integration IG v1.0 ADaM General Occurrence Model 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 With the growth of industry standards, the level of complexity increases. The expected trend is continued increase of complexity. SDTM v1.4 SDTM IG v3.1.4 Alzheimer v1.1 Asthma SEND v3.0.1 Protocol Concept Guide BRIDG UG v2 ADaM IG 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 Parkinson’s Disease Virology Content Standards Semantics Technical Standards Therapeutic Areas Pain Tuberculosis Devices BRIDG v3.1 v3.2 PRM Toolset v1.0 CDASH UG SDTM v1.3 SDTM IG v3.1.3 ADaM Val. Checks v1.2 BRIDG v3.0.1 v3.0.2 v3.0.3 Protocol Model v1.0 ADaM Val. Checks ODM v1.3.1 Alzheimer v1.0 SEND v3.0 SDTM v3.1.2 Am.1 ADaM Val. Checks v1.1 CDASH SDM.XML BRIDG v1.1.1 v2.0 v2.1 SDTM v1.2 SDTM IG v3.1.2 CDASH v1.0 Last update: September 2013 SDTM v1.1 SDTM IG v3.1.1 ODM v1.2.1 Define.xml v1.0 BRIDG v3.0 v2.2 ADaM v2.1 ADaM IG v1.0 SDTM v1.0 SDTM IG v3.1 ODM v1.2 ADaM v2.0 ODM v1.3 BRIDG v1.0 v1.1 ODM v1.1 / 2002 2005 2003 2006 2004 2007 2008 2009 2010 2011 2012 2013 2014

4 CDISC A business case by Gartner and CDISC

5 PROC CDISC : SAS first attempt to support CDISC standards
SAS response PROC CDISC : SAS first attempt to support CDISC standards SAS Clinical Standards Toolkit SAS Clinical Data Integration, SAS Drug Development

6 SAS Clinical Data Integration
Clinical Research information flow SAS EDC (Rave) Dictionary coding (TMS) External metadata (RDF, OWL, etc.) Submission data sets SDTM ADaM Others EDC (Other) Metadata, integration and standardization management SAS Clinical Data Integration SAS Drug Development Data and analytics platform Adapters / Interfaces Tables, figures and listings ePRO and others Adapters / Interfaces Metadata Pooled analyses Internal systems Adapters / Interfaces Patient Profiles/ Medical Review JMP Clinical SAS Visual Analytics Exploration across and beyond trials Labs and other external sources Raw data Transparency initiatives Real-world data Raw data

7 Still supported in SAS 9.4, but stable
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 Support for SAS table and XML files
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 From the documentation :

9 Integrate data from disparate sources
SAS CDI SAS Clinical Data Integration 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. 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

10 SAS Life Science Analytics Framework Protocol Design
Data Capture to Data Analysis CONVERSION Compound Info Life Cycle REPOSITORY EDC/CDMS Data Quality Service Detailed Data Store, Metadata Store

11 SAS Life Science Analytics Framework
A new Framework for clinical trial analytics Primary Platform Shared repository Licensing Single identity Hosting model Partner collaboration Access & audit trail 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

12 SAS & CDISC End-To-End in CDISC Data models
Validation / Adherence checks SAS code generation Macro API library and customization Metadata

13 SAS & CDISC End-To-End in CDISC : SAS CST 1.6 and SAS CDI 2.5

14 Define.xml Round Trip Sponsor Compares results to study specifications
Creates define.xml based on study specifications Sponsor Extracts metadata from implemented define.xml file DEFINE.XML Data Management Team(CRO) Extracts metadata from define.xml file Data Management Team(CRO) Produces define.xml based on implementation Data Management Team(CRO) Implements and populates domains

15 SAS Clinical Standards Toolkit
Reading the Define.xml SAS Clinical Standards Toolkit Source_*.sas7bdat DEFINE.XML %crtdds_read %sdtmutil_create Src Meta From CRTDDS %cstutil_create Tables From Metadata zero observation Domain data sets %sdtmutil_ Create Formats From CRTDDS Code List SAS Format Catalog SAS representation of CRT-DDS

16 Reading The define.xml SAS Clinical Data Integration

17 ADaM Support CDI 2.4

18 Bulk Metadata Manipulation
CDI 2.4

19 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 Visualization

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