MANAGING AND ANALYZING CLINICAL DATA MARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS BIAS MEETING, MARCH 14 TH 2014, MILAN, ITALY.
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1 MANAGING AND ANALYZING CLINICAL DATA MARK LAMBRECHT, PRINCIPAL INDUSTRY CONSULTANT, SAS BIAS MEETING, MARCH 14 TH 2014, MILAN, ITALY. 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 support Bulk metadata manipulation Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 1
2 THE CLINICAL TRIAL CHALLENGES With the growth of industry standards, the level of complexity increases. v1.1 IG v3.1.1 Define.xml ODM ODM v1.1 v1.2.1 ODM v1.3 IGv1.1 v3.1 ODM / v2.0v1.2 The expected trend is continued increase of complexity. Content Standards Technical Standards Semantics Therapeutic Areas v1.2 IG v3.1.2 CDASH v2.1 v2.0 v1.1.1 v2.1 IG v3.0 v2.2 v3.0.3 Val. Checks v3.0.2 ODM v1.3.1 v3.0.1 Protocol Model v3.1.2 Am.1 Alzheimer SDM.XML Val. Checks v1.1 CDASH v1.1 SEND v3.0 Virology Parkinson s Disease Devices v3.2 Val. Checks v1.2 v1.3 IG v3.1.3 Tuberculosis Pain PRM Toolset CDASH UG v QS Supplements CDASH E2B SAE IG MD Guide v4.0 UG v2 Define.xml v2.0 PKD CDASH v1.2 v1.4 IG v3.1.4 Associated Persons IG SEND v3.0.1 Asthma Alzheimer v1.1 IG v1.1 Protocol Concept Guide Cardiovascular Therapeutic Brain Injury Schizophrenia Oncology Virology- Hepatitis C Diabetes Multiple Sclerosis Define.xml IG Validation CDASH v2.0 v1.5 IG v3.1.5 General Occurrence Model Integration IG Extended ODM PRM XML Schema.xml SEND v3.1 Devices IG v1.1 Device Submission Pilot 2014 CDISC A BUSINESS CASE BY GARTNER AND CDISC Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 2
3 SAS RESPONSE PROC CDISC : SAS first attempt to support CDISC standards SAS Clinical Standards Toolkit SAS Clinical Data Integration, SAS Drug Development CLINICAL RESEARCH INFORMATION FLOW SAS EDC (Rave) Dictionary coding (TMS) Others External metadata (RDF, OWL, etc.) Submission data sets EDC (Other) Adapters / Interfaces SAS Clinical Data Integration Metadata SAS Drug Development Tables, figures and listings epro and others Internal systems Adapters / Interfaces Adapters / Interfaces Metadata, integration and standardization management Data and analytics platform Pooled analyses Labs and other external sources Real-world data Raw data Raw data JMP Clinical Patient Profiles/ Medical Review SAS Visual Analytics Exploration across and beyond trials Transparency initiatives Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 3
4 PROC CDISC Still supported in SAS 9.4, but stable Support for reading ODM 1.2 and 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 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 Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 4
5 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 Protocol Design Data Capture to Data Analysis CONVERSION Compound Info Life Cycle REPOSITORY SAS Life Science Analytics Framework EDC/CDMS Data Quality Service Detailed Data Store, Metadata Store Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 5
6 SAS LIFE SCIENCE ANALYTICS FRAMEWORK A NEW FRAMEWORK FOR CLINICAL TRIAL ANALYTICS Primary Platform Shared repository Single identity Partner collaboration Analysis & Regulatory Controls Data Standards Repository Licensing Hosting model Access & audit trail Information Management Operations & Optimization Other SAS Offerings Workflow Study & standards metadata Mapping Risk based scoring and monitoring Visual Analytics Compliance Import/export metadata Instance data standards Post marketing & safety surveillance Data Transparency Analysis processes Connects protocol/study design Integration (EDC, Safety, epro, etc.) Site selection/ management Enterprise Miner Process traceability Manage controlled terminology Data traceability/ lineage Patient recruitment others SAS & CDISC END-TO-END IN CDISC Data models Metadata Validation / Adherence checks Macro API library and customization SAS code generation Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 6
7 SAS & CDISC END-TO-END IN CDISC : SAS CST 1.6 AND SAS CDI 2.5 SEND 3.0 standard support support 2.1 updates Integration with Medidata Rave / EDC up to 3.2 ( 1.4 IG) ODM support Extract Clinical and Reference data into SAS datasets Custom domain promotio n an d standards gov ernan ce CRT-DDS 1.0 support Validate Toolkit metadata Incremental and granular standards upd ate in SAS CDI Import and export define.xml files up to 3.2 ( IG) Import, S DTM and SEND information from define.xml Define-XML 2.0 support Controlled terminology support SAS Clinical Standards Toolkit SAS Clinical Data Integration Updates to macro framework Full UTF-8 and S-JIS code support Code runs everywhere DEFINE.XML ROUND TRIP Sponsor Compares results to study specifications Sponsor 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 Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 7
8 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 SAS representation of CRT-DDS %sdtmutil_ Create Formats From CRTDDS Code List SAS Format Catalog READING THE DEFINE.XML SAS CLINICAL DATA INTEGRATION Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 8
9 ADAM SUPPORT CDI 2.4 BULK METADATA MANIPULATION CDI 2.4 Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 9
10 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 qualityclinical data VISUALIZATION Copyr ight 2013, SAS Inst it ut e Inc. All r ight s r eser ved. 10
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