© 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data...
-
Upload
violet-stone -
Category
Documents
-
view
217 -
download
0
Transcript of © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data...
![Page 1: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/1.jpg)
© 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
![Page 2: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/2.jpg)
© 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
![Page 3: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/3.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.3
Agenda
• Background• Standards Governance• People• Standards• Processes• Technical Solutions
![Page 4: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/4.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.4
Background
![Page 5: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/5.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.5 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.5
Standards
Who needs them ????
![Page 6: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/6.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.6 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.6
Standards
Success story !!!!
![Page 7: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/7.jpg)
© 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
![Page 8: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/8.jpg)
© 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
![Page 9: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/9.jpg)
© 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
![Page 10: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/10.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.10
Standards Governance
![Page 11: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/11.jpg)
© 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
![Page 12: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/12.jpg)
© 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
![Page 13: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/13.jpg)
© 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
![Page 14: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/14.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.14
People
![Page 15: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/15.jpg)
© 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
![Page 16: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/16.jpg)
© 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!
![Page 17: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/17.jpg)
© 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
![Page 18: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/18.jpg)
© 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
![Page 19: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/19.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.19
Standards
![Page 20: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/20.jpg)
© 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
![Page 21: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/21.jpg)
© 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
![Page 22: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/22.jpg)
© 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
![Page 23: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/23.jpg)
© 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?
![Page 24: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/24.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.24
Processes
![Page 25: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/25.jpg)
© 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
![Page 26: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/26.jpg)
© 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
![Page 27: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/27.jpg)
© 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
![Page 28: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/28.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.28
Technical Solutions
![Page 29: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/29.jpg)
© 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)
![Page 30: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/30.jpg)
© 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.)
![Page 31: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/31.jpg)
© 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
![Page 32: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/32.jpg)
© 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
![Page 33: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/33.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.33
Summary
![Page 34: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/34.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.34
• Standards Governance– People– Standards– Processes– Technical Solutions
![Page 35: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/35.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.35 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.35
• Spend time thinking up-front
![Page 36: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/36.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.36 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.36
• Avoid herding cats
![Page 37: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/37.jpg)
© 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
![Page 38: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/38.jpg)
© 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)
![Page 39: © 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research.](https://reader030.fdocuments.us/reader030/viewer/2022033106/56649da15503460f94a8d985/html5/thumbnails/39.jpg)
© 2010 Octagon Research Solutions, Inc. All Rights Reserved.39
Questions
?