Post on 23-Dec-2015
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.1
Initial Investment in CDISC Data Standards
in Clinical Organisations
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.
Ken StoltzfusOctagon Research Solutions
PhUSE 2010 Berlin
Knitting fog, herding cats, and other challenging endeavours
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.2
About Octagon
• Octagon Research Solutions– A development partnering organization that offers regulatory,
clinical, process and IT solutions to the life sciences industry.
• Octagon experience on topic:– 600 studies converted to SDTM & ADaM (8,000+ domains)– Current CDISC SDS team lead– 2 of 6 co-authors of CDISC SDTM– Current CDISC team membership: SDS, ADaM, Trial
Design, Controlled Terminology, and XML– CDISC-authorized SDTM trainers
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.3
Agenda
• Background• Standards Governance• People• Standards• Processes• Technical Solutions
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.4
Background
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.5 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.5
Standards
Who needs them ????
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.6 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.6
Standards
Success story !!!!
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.7 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.7
Value
• Example: Analysis and Submission – Integrated standards provide traceability when the
regulatory reviewer has questions – Data mining for safety signals facilitated by
adherence to a common standard structure– Emerging regulatory standards yield reviews with
decreased review time and increased data accuracy
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.8 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.8
Metrics
Clinical Study Activities
Current Industry Average(months)
After CDISC Standards
Implementation (months)
Time Savings (months)
Cost Savings
(USD Million)
Study Start-up 5 1 4 4.4
Study Conduct 4 2.4 1.6 1.8
Analysis & Reporting 5 2.5 2.5 2.8
Cumulative 14 5.9 8.1 9
Impact of CDISC Standards Implementation
on Clinical Study Cycle Time & Cost1
1 “Business Case for CDISC Standards: Full Report, PhRMA-Gartner-CDISC Project” (May 2007), http://www.cdisc.org
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.9 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.9
Obstacles
• Acknowledging the fears– Inhibiting scientific innovation– Perception of standards governance as bureaucracy– Business needs compete with standards needs– Unacceptable cost in time and resources– The standards will not be stable
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.10
Standards Governance
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.11 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.11
Standards Governance
• What exactly is standards governance?– Oversight– Decision-making– Development– Maintenance– Compliance – Enforcement
Solution:
Standards Governance Framework
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.12 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.12
Standards Governance
• Standards – Governance = No standards at all– Irregular, non-compliant usage– Eventually non-existent
• Minimum framework:– Roles & responsibilities– Development resources– Business guidelines
• Maximum framework:– Processes– Tools
Standards Governance Framework
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.13 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.13
Standards Governance
• Standards
• People
• Processes
• Technical Solutions
Leadership
Content decision-makers
Developers
Data stewards
Internal standards
CDISC standards
Interpretation
Development
Business Guidelines
Maintenance
SOPs
Request system
CDR
MDR
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.14
People
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.15 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.15
People
• Numbers– Varies from company to company– Part-time resources far outnumber the full-time ones
• Full-time– Team leader(s)– Decision-makers (content & structure)
• Part-time– Oncology physician for RECIST tumor measurements– EDC screen developer including monitoring needs in eCRF– Statistical programmer writing standard macro code– IT rep as liaison - governance group to IT project managers
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.16 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.16
People
• Content decision-makers– Subject matter experts (medical, clinical, statistical)
• Developers– Technical expertise– Operational managers
• Administrators– Tracking requests– Updating metadata– Uploading the latest version
• Data Stewards– TAs– Functional areas
Don’t forget the
IT function!
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.17 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.17
People
• High-level directive that creates buy-in– Improved data quality
– Improved data transparency
– Accurate, consistent submissions
– Speed of study execution
– Maximization of study execution resources
– Cost savings
– Compliance with anticipated regulatory requirements
– Keeping up with competitors who are becoming more streamlined
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.18 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.18
People
• Definition of standards drivers– Bridge gap between the strategic & operational– Working knowledge of standards (doesn’t have to
be a standards expert)– A champion for standards in their functional area
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.19
Standards
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.20 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.20
Standards
• What are Standards ????– A company’s methodology in a stable format– Intellectual property in some cases– Internal vs external– Reusable pieces used in clinical trials
• Data definition files• eCRF screens• EDC data extracts• Data checking utilities/programs• Macros for standard results• Analysis dataset programs• XML transfer files
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.21 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.21
Standards
• 80 / 20 rule
20: Only 20% of total content that a function delivers for a study should come from customized or newly developed standards
80: Of the total content that a function delivers for a study, 80% should come from quick, efficient, reusable standards
Custom
Reusable
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.22 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.22
Standards
• Levels to facilitate management of standards
– Global– Therapeutic Areas– Project
Custom
Reusable
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.23 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.23
Standards
• SDTM implementation considerations– SDTM Findings class in collection: horizontal vs vertical– SDTM mapping: stability of standard CRFs– Best location in the data lifecycle for conversion to SDTM– SDTM experience in the EDC functional area – Linear implementation: CDASH to SDTM to ADaM– Which databases house data needed to build Trial Design? – SDTM & ADaM metadata – Define.xml: How? Who?– SDTM training: Who? What? When?
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.24
Processes
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.25 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.25
Processes
• Governance charter– Strategic– Structure– Organisation– Roles & Responsibilities– Scope
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.26 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.26
Processes
• Standard Operating Procedures (SOPs)– Development of standards– Maintenance of standards– Request process for new or revised standards– Role of the data steward in governance– Access control for standards storage – Waiver process
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.27 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.27
Processes
• Business Guidelines for CDISC Standards– Mapping decisions– Common practices– Interpretation
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.28
Technical Solutions
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.29 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.29
Technical Solutions
• Do they really help ???
• Technical solutions that make a difference– Standards request system– Clinical data repository (CDR)– Metadata repository (MDR)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.30 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.30
Technical Solutions
• Standards Request System– The face of the standards governance framework – Allow study teams to submit standards requests– Allow for supportive files – Assign unique identification number – Track requests by date, resolution, user, etc.– Fulfill request with discussions, questions, and
decisions– Provide users with status of their requests– Provide reporting capabilities (metrics, etc.)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.31 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.31
Technical Solutions
• Clinical Data Repository– Repose all data in standard centralized location– Import, storage, and export of data in SDTM– Validated inbound ETL process – Promote standardized, validated data import and
export– Support the production of analysis datasets and
clinical study reports– Interoperability with clinical systems across the
clinical data architecture
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.32 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.32
Technical Solutions
• Metadata Repository– Repose all metadata in standard centralized location
– Repose study definition metadata
– Ensure areas for all standards (global, TA, project)
– Import and export standards metadata
– Interoperability with clinical systems across the clinical data architecture
– Generate governance process workflows
– Maintain proper version control, data traceability & audit trails
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.33
Summary
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.34
• Standards Governance– People– Standards– Processes– Technical Solutions
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.35 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.35
• Spend time thinking up-front
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.36 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.36
• Avoid herding cats
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.37 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.37
Acknowledgements
Barry Cohen
Dave Evans
Tore Haglund
Stephen Harrison
Harpreet Sahni
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.38
Contact Information
Ken Stoltzfus
Clinical Data Strategies
Octagon Research Solutions
585 East Swedesford Road, Suite 200
Wayne, PA 19087
USA
Tel: 1-610-535-6500 (Ext. 5891)
kstoltzfus@octagonresearch.com
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.39
Questions
?