SAS Drug Development in action: efficient standards libraries and study management modules together called CDmation.

Transcription

1 SAS Drug Development in action: efficient standards libraries and study management modules together called CDmation. Mark Lambrecht (SAS) Peter Van Reusel (Business & Decision Life Sciences)

2 The clinical trial challenges ODM ODM v1.1 v1.2.1 With the growth of industry standards, the level of complexity increases. The expected trend is continued increase of complexity. Content Standards Technical Standards SDTM v1.1 SDTM IG v3.1.1 Define.xml v1.0 SDTM ODM v1.0 BRIDG v1.3 SDTM IG v1.1 v3.1 ADaM ODM / v2.0 v1.2 BRIDG v1.0 Semantics Therapeutic Areas SDTM v1.2 SDTM IG v3.1.2 CDASH v1.0 BRIDG v2.1 BRIDG v2.0 BRIDG v1.1.1 ADaM v2.1 ADaM IG v1.0 BRIDG v3.0 BRIDG v2.2 BRIDG v3.0.3 ADaM Val. Checks v1.0 BRIDG v3.0.2 ODM v1.3.1 BRIDG v3.0.1 Protocol Model v1.0 SDTM v3.1.2 Am.1 Alzheimer v1.0 SDM.XML v1.0 ADaM Val. Checks v1.1 CDASH v1.1 SEND v3.0 Virology Parkinson s Disease Devices BRIDG v3.2 ADaM Val. Checks v1.2 SDTM v1.3 SDTM IG v3.1.3 Tuberculosis Pain PRM Toolset v1.0 CDASH UG v1.0 BRIDG v3.1 SDTM QS Supplements CDASH E2B SAE IG ADaM MD Guide BRIDG v4.0 BRIDG UG v2 Define.xml v2.0 PKD CDASH v1.2 SDTM v1.4 SDTM IG v3.1.4 SDTM Associated Persons IG v1.0 SEND v3.0.1 Asthma Alzheimer v1.1 ADaM IG v1.1 Protocol Concept Guide Cardiovascular Therapeutic Brain Injury Schizophrenia Oncology Virology- Hepatitis Diabetes C Multiple Sclerosis Define.xml IG Validation CDASH v2.0 SDTM v1.5 SDTM IG v3.1.5 ADaM General Occurrence Model v1.0 ADaM Integration IG v1.0 Extended ODM PRM XML Schema SDTM.xml v1.0 SEND v3.1 SDTM Devices IG v1.1 SDTM Device Submission Pilot Restricted SAS 2006 Institute 2004 and 2007 Business & Decision 2008 Life Sciences All 2010 rights reserved

3 Agenda Introduction SAS Drug Development CDmation Use Cases Reports in SAS Drug Development

4 Clinical Trials Process FROM DATA CAPTURE THROUGH ANALYSIS AND SUBMIISSION INTEGRATION TRANSFORMATION ANALYSIS REPORTING SUBMISSION POST SUBMISSION Legacy Acquired EDC SAS DRUG DEVELOPMENT: Clinical Trials Analysis & Reporting SUBMISSION DATA SETS Data Repository AGGREGATED DATA SETS PUBLICATION S THERAPEUTIC INSIGHT TRIAL DESIGN & PLANNING NEW MARKETING CLAIMS LAB OTHER EXT. DATA CDMS RAW DATA SETS AE ANALYSIS DATA SETS AE ANALYSIS STATISTICAL REPORT(S) READY FOR SUBMISSION SAFETY REPORT(S)

5 SAS and the Next Generation of Clinical Research Collaboration and Access Confidence and Control Process Improvements Advanced Analytics Accessanywhere web interface User, team and role-based access Messaging and alerts Shared libraries Compliant, regulated environment Activity traceability Transparency Reproducibility Workflow support and process orchestration eprotocol, EDC and esubmission integration Automated work assignments and transitions Scientific analytics Business analytics Data exploration Data visualization

6 Clinical Data Analysis and Reporting Business Needs Submission and regulatory support Analysis authoring and execution Work organization, management and optimization Auditing, traceability and reproducibility Clinical Data Analysis and Reporting Data aggregation and secure storage Workflow, activity management and process orchestration Collaboration and controlled access

7 Needs for a metadata management solution versus SDD OK Robust platform to cover other parts of clinical data management and statistics Need to store data Need to have several workflows Capability to execute SAS code Traceability, security and audit Reporting capabilities But UI for granular data standards management Study specification process Study validation process

8 Come to the rescue Robust SDD Application Programming Interface SDD 4.X JAVA API OVERVIEW Package com.sas.hls.client Class SessionFactory Session ServiceManager public static Session newsession( URL url, String userid, String password) getservicemanager() DrugServiceManager

9 SDD = extensible and modular User Interface User interface SAS Drug Development User interface extended applications : CDmation Clinical Data Manager Statistical Programmer 1 session 1 user experience Data Standards Library Management Standards Admin Study Specification Study Metadata Study Admin Study Validation Study Management Administration Study Project Owner Medical Writer Service layer SDD API Application layer SAS programs Study data Files SAS DRUG DEVELOPMENT 4 Repository Define.xml Workspace SAS datasets SDD User information Audit log SDD object metadata (security) SDD Remote API Application Server CDmation JAVA Oracle database Data standard library Study metadata repository Audit trail Documents Work flow Outputs Application Server Issue tracking

10 Agenda Introduction SAS Drug Development CDmation Use Cases Reports in SAS Drug Development

11 CDmation An integrated solution with six components:

12 CDmation s playing field DATA COLLECTION AREA SDD DATA MANAGEMENT AREA DATA STANDARDS LIBRARY DBA STUDY SPECIFICATION DBA STUDY METADATA REPOSITORY DM VALIDATION EDC STUDY STUDY METADATA METADATA SPECIFICATION SPECIFICATION COMPARISON ISSUE REPORTS ISSUE REPORTS CRO RAW DATA & METADATA SPECIFICATION STUDY SDTM DATA & METADATA DEFINE.XML

13 Functionalities DATA COLLECTION AREA DATA MANAGEMENT AREA Library Management DATA STANDARDS LIBRARY DBA STUDY SPECIFICATION HOSTING STUDY METADATA REPOSITORY DM VALIDATION EDC STUDY METADATA SPECIFICATION ISSUE REPORTS COMPARISON ISSUE REPORTS CRO STUDY SDTM DATA & METADATA DEFINE.XML

14 Functionalities DATA COLLECTION AREA SDD DATA MANAGEMENT AREA DATA STANDARDS LIBRARY Study design DBA STUDY SPECIFICATION HOSTING STUDY METADATA REPOSITORY DM VALIDATION EDC STUDY METADATA SPECIFICATION ISSUE REPORTS COMPARISON ISSUE REPORTS CRO STUDY SDTM DATA & METADATA DEFINE.XML

15 Functionalities DATA COLLECTION AREA SDD DATA MANAGEMENT AREA DATA STANDARDS LIBRARY DBA STUDY SPECIFICATION EDC HOSTING STUDY METADATA SPECIFICATION STUDY METADATA REPOSITORY Study conduct & close-out DM VALIDATION ISSUE REPORTS COMPARISON ISSUE REPORTS CRO STUDY SDTM DATA & METADATA DEFINE.XML

16 CDmation Roadmap EDC Build Extend library to include Analysis Standards Generate Analysis

17 Agenda Introduction SAS Drug Development CDmation Use Cases Reports in SAS Drug Development

18 Use Case 1 Study Specification Study Specification and Metadata Repository Pick and Select study creation Creation of Trial Design specifications Defines all study specifications in a controlled manner Allows generating a study metadata repository for comparison reporting within and across studies Generates a define.xml upfront Ensures CDISC compliant study specifications for your CRO early in the process, maintains data consistency, facilitates submission activities and increases overall quality and reduces rework

19 Data Standards Library The Data Standards Library contains : Data Collection Modules: using CDASH metadata with clustered SDTM metadata annotated for CDASH annotated for SDTM front end edit checks CRF completion Instructions Metadata Definitions : SDTM Standards Therapeutic Area Standards DATA COLLECTION MODULES EDIT CHECKS CRF INSTRUCTIONS SDTM 1.3 SDTM IG THERAPEUTIC AREA METADATA DATA STANDARDS LIBRARY

20 Data Collection Modules - CDASH DATA COLLECTION MODULES LIBRARY DM 1 DM 2 VS 1 VS 2 EG 1... CRF template using CDASH annotations

21 Data Collection Modules - SDTM DATA COLLECTION MODULES LIBRARY DM 1 DM 2 VS 1 VS 2 EG 1...

22 Study Specification Create Pick Enter and Visit Trial Select Schedule Design DCM

23 Define.xml

24 Use Case 2 Study Validation Study Validation Comparison reports against specifications Validation performed on structural and content level Output in Excel spreadsheet, HTML and PDF report Output also stored in the Feedback Tracker Ensures improved vendor communication, CDISC compliance and readiness, increases quality, reduces rework.

25 Select checks => Create Job

26 Run job => Review issues Reported Exception Record Identifiers Exception Attributes

27 Manage Issues Issue Details Comments Status History Variable Details

28 Agenda Introduction SAS Drug Development CDmation Use Cases Reports in SAS Drug Development

29 REPORTING possibilities EXECUTABLE JAR FILES JAVA PROGRAMS ECLIPSE JAVA SAS JAVAOBJ SDD JAVA API SAS PROGRAMS SAS SDD SAS IOM + VBA OFFICE Additional Capabilities: 1. SAS Programs / Macros 2. Java Programs 3. Java JARs 4. Java Executable exe files 5. Microsoft Excel Graphical capabilities EXCEL FILES

30 Reporting capability SAS ENVIRONMENT ORACLE DATABASE SAS PROGRAMS DATA STANDARD LIBRARY STUDY METADATA REPOSITORY STUDY DATA DEFINE.XML SAS DATASETS ISSUE TRACKING AUDIT TRAIL FILES DOCUMENTS OUTPUTS Data Standards Library Comparison Implementation Guides Completion Guides Trial summary-based search reports Metrics reports Study metadata comparison across study versions Study metadata comparison across projects Define.xml Export of trial design datasets Study metadata-based search reports

31 Reporting capability (1) Data Standards Library Comparison

32 Reporting capability (2) Implementation Guides

33 Reporting capability (3) Study Metadata Comparison 2 different statuses: Ok : no metadata conflict Difference : difference in metadata value between studies

34 SAS Drug Development integration with CDMation SAS Drug Development = open extensible platform Integration 1. User access and security model Re-use system metadata, login session of SDD Integrated user experience (including single sign-on) Integrated user roles & privileges 2. Audit trail and permission reports Access from SDD-executed SAS code to all metadata from SDD and CDMation (audit trail, permissions) 3. Metadata validation flow across all parts Jobs (SAS programs) running in controlled execution environment with complete access to CDMation standards and study metadata One integrated repository for jobs, documents and other output

35 Thank you Brussels, FSUG, May 22nd 2014

36 Mark Lambrecht Principal Consultant Health and Life Sciences Global Practice SAS T Peter Van Reusel COO Businesss & Decision Life Sciences T Business & Decision Life Sciences Sint-Lambertusstraat rue Saint-Lambert B-1200 Brussels T: F: lifesciences@businessdecision.com SAS Institute Inc. 100 SAS Campus Drive Cary, NC , USA