© 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research

© 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


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


Agenda

• Background• Standards Governance• People• Standards• Processes• Technical Solutions


Background

© 2010 Octagon Research Solutions, Inc. All Rights Reserved.5 © 2010 Octagon Research Solutions, Inc. All Rights Reserved.5

Standards

Who needs them ????


Standards

Success story !!!!


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


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


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


Standards Governance



• What exactly is standards governance?– Oversight– Decision-making– Development– Maintenance– Compliance – Enforcement

Solution:

Standards Governance Framework



• 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



• 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


People


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


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!


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


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


Standards


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


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


Standards

• Levels to facilitate management of standards

– Global– Therapeutic Areas– Project

Custom

Reusable


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?


Processes


Processes

• Governance charter– Strategic– Structure– Organisation– Roles & Responsibilities– Scope


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


Processes

• Business Guidelines for CDISC Standards– Mapping decisions– Common practices– Interpretation


Technical Solutions


Technical Solutions

• Do they really help ???

• Technical solutions that make a difference– Standards request system– Clinical data repository (CDR)– Metadata repository (MDR)


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.)


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


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


Summary


• Standards Governance– People– Standards– Processes– Technical Solutions


• Spend time thinking up-front


• Avoid herding cats


Acknowledgements

Barry Cohen

Dave Evans

Tore Haglund

Stephen Harrison

Harpreet Sahni


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)

[email protected]


Questions

?

Documents

© 2010 Octagon Research Solutions, Inc. All Rights Reserved. 1 Initial Investment in CDISC Data Standards in Clinical Organisations © 2010 Octagon Research