October, Integration and Implementation of CDISC Standards

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1 Integration and Implementation of CDISC Standards October, 2008 Barbara Lentz, Associate Director, Electronic Data Management Standards, Processes & Training Pat Majcher, Statistical Reporting Services Gina Wood, Global Head, Statistical Reporting Services

2 Agenda Introduction Overview of the New Landscape Strategy Overview Part 1 Technical Projects Beyond the Technical Strategy Overview Part 2 Interim Activities Summary 2 Integration and Implementation of CDISC Standards October, 2008

3 Introduction (1/2) * CDISC= Clinical Data Interchange Standards Consortium Novartis vision Continuously transform the development of drugs through the integration of technologies, innovative approaches, and skills in close partnership with external stakeholders and decision makers to develop better and safer medicines and provide them to patients faster Maximize the value of clinical data to increase significantly the ability to analyze safety data proactively, enable modeling and simulation, and increase operational efficiency A key enabler of this vision: clinical data standards, utilizing CDISC* models Novartis is approaching the challenge of implementing CDISC standards via several distinct but overlapping efforts 3 Integration and Implementation of CDISC Standards October, 2008

4 Introduction (2/2) Benefits of achieving this vision Comply with expected health authority regulations Ensure that the data from all studies conducted on a drug product or across drug products within a therapeutic area can be easily combined - Support aggregated reporting for regulatory submissions, commercialization, product defense, data mining, and modeling and simulation Facilitate data review and data exchange Facilitate data integration with external sources (e.g., electronic health records, epidemiology data) 4 Integration and Implementation of CDISC Standards October, 2008

5 Overview of the New Landscape Electronic Protocol Data Capture Modeling& Simulation Projectspecific Metadata Library Database Data Warehouse Global Metadata Repository Define.xml Derived Data Analysis & Reporting System Programming Environment Analysis Datasets Document Management System Tables, Listings, and Graphs Submission Datasets SDTM & ADaM Submission Package (FDA) 5 Integration and Implementation of CDISC Standards October, 2008

6 Strategy Overview Part 1 Initiate multiple projects to address different aspects of data standards Projects are coordinated through a high-level program, with appropriate management support Identify key internal stakeholders and ensure proper representation across projects Partner with external consultants and technology vendors, as appropriate Identify non-technical areas requiring attention, e.g., change management, training, etc. 6 Integration and Implementation of CDISC Standards October, 2008

7 Technical Projects Data Standardization Data Collection and Storage Clinical Data Analysis and Reporting System Other Projects 7 Integration and Implementation of CDISC Standards October, 2008

8 Data Standardization (1/5) * SDTM = Study Data Tabulation Model * ADaM = Analysis Data Model Foundation for other projects Two major streams, definition of data elements and usage of metadata Data element definition Defines the data items supporting data collection, SDTM*, and ADAM* Standard SDTM domains addressed - Work is underway for efficacy domains Other project deliverables - Business Guidance, Governance Process, Training 8 Integration and Implementation of CDISC Standards October, 2008

9 Data Standardization (2/5) * CDASH = Clinical Data Acquisition Standards Harmonization Data element definition (continued) Each data element assessed: - Which functional areas use it? Which tools/systems? - Representatives from all relevant groups included to ensure consistency throughout the process E.g., data collection analysis and reporting modeling and simulation - Process ensures that all applications use the variables in the same way, i.e., with the same definition and implementation 27 data element attributes documented, including definition, type, length, data entry screen and SAS labels, owner (e.g., CDASH*, SDTM), domain, role, used for data repository/adam/sdtm, etc. Also documents derivations, codelists, decisions, and instructions to clinical sites 9 Integration and Implementation of CDISC Standards October, 2008

10 Data Standardization (3/5) Data Element Definition Example CRF Domain Domain Type Data Element SAS Variable Name Screen & SAS Label Definition DM Special BRTHYR N/A Year of birth Year of subject's birth All DM Special BRTHMO N/A Month of birth Month of subject's birth All DM Special BRTHMO_CT N/A Month of birth Month of subject's birth All DM Special BRTHMO_LN N/A Month of birth Month of subject's birth All DM Special BRTHDY N/A Day of birth Day of subject's birth All Visible on ecrf Screen Derivation/ Imputation name Data Data SDTM Controlled Generic Collection Repository SDTM Domain Origin Owner Terminology Type Yes Yes No N/A Entered N/A CDASH N/A Text Char No Yes No N/A Derived N/A CDASH BRTHMO Text Char Yes Yes No N/A Entered N/A NCT BRTHMO Integer Num Yes Yes No N/A Derived N/A NCT BRTHMO Text Char Yes Yes No N/A Entered N/A CDASH N/A Text Char Display Type 10 Integration and Implementation of CDISC Standards October, 2008

11 Data Standardization (4/5) Metadata applications Global Metadata Repository (MDR) - Central registry of all data domains, data elements, and codelists the superset of all data standards Putting it all together Technical integration architecture MDR Data element registration Data standardization and governance 11 Integration and Implementation of CDISC Standards October, 2008

12 Data Standardization (5/5) Metadata applications (continued) Project-specific metadata library - Enable electronic access to operational metadata - A central registry of data domains, data elements, and codelists used for a specific therapeutic area, compound, indication, or trial for data collection and reporting Benefits - Set up trials more efficiently with improved quality - Measurement and enforcement of standards usage; change control of standards - Enable other systems and tools (e.g., database tools, electronic protocol, data analysis and reporting system, define.xml) - Improve data pooling capabilities to support submissions, safety signal detection, and modeling and simulation 12 Integration and Implementation of CDISC Standards October, 2008

13 Data Collection / CDASH Clinical Data Acquisition Standards Harmonization, CDASH Initiative to develop standard Case Report Form (CRF) content to be used across the industry Included in Food and Drug Administration (FDA) Critical Path Initiative CDASH specifications include definition, controlled terminology, designation of mandatory/conditional/optional, names, applicable regulations, instructions to sites, etc. Benefits - Investigator familiarity will improve quality of data collected - Facilitate exchange of data between development partners, between sponsors and Contract Research Organizations - Alignment with SDTM Clinical Database Management System Application suite: thesaurus management, data capture, and global library (implementation of Data Element Definition decisions) 13 Integration and Implementation of CDISC Standards October, 2008

14 Data Storage Clinical data repository Data warehouse environment, source of all collected data and relevant analysis data Enable end users to focus more on business intelligence and analytics, rather than technical details Functionality includes - Ability to create pooled data specific to user needs (data marts on demand) - Versioning of data, models; audit trail - Different work areas, specific to each business need 14 Integration and Implementation of CDISC Standards October, 2008

15 Clinical Data Analysis and Reporting System Software which integrates current and new reporting processes, systems, and paper-based modules, while aligning with CDISC data models Objectives Greater emphasis on capturing/storing/using metadata - E.g., any reporting activity metadata not captured in the clinical database will be entered manually (interim solution) or obtained directly from electronic protocol (longer-term solution) Automated creation/compliance validation of SDTM/ADaM data sets Automated creation of define.xml Reports on resources and metrics Simplified workflow process as new software integrates different activities in the business area 15 Integration and Implementation of CDISC Standards October, 2008

16 Other Projects (1/2) Define.xml Tool to generate and verify define.xml files Will be accessible through the new Clinical Data Analysis and Reporting System Increase automation of file creation, improving quality of deliverables Data Conversion Software and business processes to enable conversion of data from one standard to another Data will be made available in the central data repository Enable integration of data to support submissions, data mining, modeling and simulation, and other critical activities 16 Integration and Implementation of CDISC Standards October, 2008

17 Other Projects (2/2) Electronic protocol Support compliance to emerging standards for protocol structured into data elements Author protocols through annotated data elements-based template Support downstream activities (e.g., data collection, statistical analysis, clinical trial registry) Benefits - Improve quality by reducing redundancy and inconsistencies - Increase efficiency in generating study protocols and related documents 17 Integration and Implementation of CDISC Standards October, 2008

18 Beyond the Technical Business Guidance Governance People External Organizations 18 Integration and Implementation of CDISC Standards October, 2008

19 Business Guidance Purpose Provide clear guidelines for the use and population of the clinical data domain template Provide rules for the creation of new clinical domains or data elements Describe the processes and best practices concerning data collection, storage, and reporting Discuss relationship of Data Element Definitions to the central data repository, the CDISC models, define.xml files Present examples - E.g., trial design domains for parallel and crossover studies 19 Integration and Implementation of CDISC Standards October, 2008

20 Governance Defined by a committee with representatives from relevant functions Clinical, Biostatistics, Programming, Data Management, Metadata Repository Administrator, etc. Governance Process Document Details the procedures and controls required to create or modify domains, domain elements, and controlled terminology Describes guiding principles, roles and responsibilities, the communication model 20 Integration and Implementation of CDISC Standards October, 2008

21 People (1/2) New roles created Global Line Function Coordinators, key people within line functions who support and communicate implementation of the standards Metadata Repository Administrator, responsible for maintaining the MDR Management support Sustain management support to drive change and maximize benefit Enable investment in new/enhanced technology 21 Integration and Implementation of CDISC Standards October, 2008

22 People (2/2) Communications Ongoing series of presentations to staff at all sites to keep them apprised of updates on data standards, projects, CDISC, etc. Formal training Material based on different roles within the organization and access needed to specific systems Topics include data element definition, business guidance, governance model, and change management 22 Integration and Implementation of CDISC Standards October, 2008

23 External Organizations (1/2) * BRIDG = Biomedical Research Integrated Domain Group Novartis participates in external teams and meetings Learn about latest processes and tools Influence industry positions CDISC initiatives Participation in CDISC subgroups - CDASH - Japan CDISC Coordinating Committee - Trial Design Model - CDISC-BRIDG*-Technical harmonization committee CDISC User Group meetings attended by colleagues in Europe, Japan, and US 23 Integration and Implementation of CDISC Standards October, 2008

24 External Organizations (2/2) HL7, Health Level 7 subgroups - RCRIM (Regulated Clinical Research Information Management) - CDISC Content to Message PhRMA CDISC-related teams Biostatistics and Data Management Technical Group (BDMTG) Best Review Practices team SDTM and Analysis Datasets Expert team Other industry teams CDE, Clinical Data Elements repository 24 Integration and Implementation of CDISC Standards October, 2008

25 Strategy Overview Part 2 How to meet the challenge of CDISC submissions before the new systems and processes are in place? Other initiatives ongoing to bridge the gap in the interim Resulting data/information also used as input to longer-term projects 25 Integration and Implementation of CDISC Standards October, 2008

26 Data Conversion SDTM Submissions ADaM Data Interim Activities 26 Integration and Implementation of CDISC Standards October, 2008

27 Data Conversion CDISC Migration Project Starting point: data in Novartis legacy model Identify external partner(s) who can provide us with not only mapped clinical data but supporting metadata Map to Novartis new standard - Goal is to expand Novartis experience with data conversion and submission tools and processes, as well as the associated metadata Learn about the tool(s) used by external partners - Test the process drafted by the Data Conversion team - Mapped data can be used internally for data pooling and other purposes, such as test data for new systems 27 Integration and Implementation of CDISC Standards October, 2008

28 SDTM Submissions Sample submissions Novartis has provided two samples to FDA s Office of Business Process Support - Test internal tools and processes - Identify any potential issues prior to official SDTM submissions - Gain familiarity with tools used by FDA (e.g., WebSDM, Web Submission Data Manager) Official submissions Evaluate health authority requests for SDTM data; decide with which requests Novartis can agree Currently working on one request from FDA Supplement internal resources with external partners - Where additional expertise or personnel needed 28 Integration and Implementation of CDISC Standards October, 2008

29 ADaM Data Currently partnering with external CDISC expert Learning the details of the ADaM model Reviewed and provided comments on the current draft version to CDISC Defined all standard safety outputs Will be utilized in the new analysis and reporting environment SDTM and ADaM data produced automatically 29 Integration and Implementation of CDISC Standards October, 2008

30 Summary Lessons Learned Contacts 30 Integration and Implementation of CDISC Standards October, 2008

31 Lessons Learned (1/2) Enforcement Assure buy-in from all stakeholders Provide easier access to current standards so users know what is currently available - Intuitive tool, minimal end user training Metadata repository should drive the development of new data elements and controlled terminology Clear change management process Process for requesting new/modifying elements must respect time pressures of clinical trials; expedited process needed 31 Integration and Implementation of CDISC Standards October, 2008

32 Lessons Learned (2/2) Standards are evolving and will continue to evolve Keep up-to-date with changes and developments Adapt strategy, as needed Continue alliances with external organizations Continue collaboration within Novartis with different business/functional areas to leverage respective experience and knowledge 32 Integration and Implementation of CDISC Standards October, 2008

33 Contacts Barbara Lentz: Pat Majcher: Georgina Wood: 33 Integration and Implementation of CDISC Standards October, 2008

34 Questions? Comments? Thank you for your time & attention 34 Integration and Implementation of CDISC Standards October, 2008

35 Backup Slides 35 Integration and Implementation of CDISC Standards October, 2008

36 Acronyms (1/2) ADaM = Analysis Data Model BDMTG = Biostatistics and Data Management Technical Group BRIDG = Biomedical Research Integrated Domain Group CDASH = Clinical Data Acquisition Standards Harmonization CDISC = Clinical Data Interchange Standards Consortium CRF = Case Report Form FDA = Food and Drug Administration 36 Integration and Implementation of CDISC Standards October, 2008

37 Acronyms (2/2) HL7 = Health Level 7 MDR = Metadata Repository PhRMA = Pharmaceutical Research and Manufacturers of America RCRIM = Regulated Clinical Research Information Management SDTM = Study Data Tabulation Model WebSDM = Web Submission Data Manager 37 Integration and Implementation of CDISC Standards October, 2008

CDISC Standards: Current and Future

CDISC 2010 CDISC Standards: Current and Future CDISC Japan Interchange Tokyo, Japan 20 July 2010 Rebecca D. Kush, PhD President and CEO, CDISC Clinical Research Standards (Content) (Protocol-driven Research;