Transcript CDISC Strategy Joint Initiative Council 18 October 2011 Bron Kisler, VP, Strategic Initiatives, Current JIC Leader Rebecca D.

CDISC Strategy
Joint Initiative Council
18 October 2011
Bron Kisler, VP, Strategic Initiatives, Current JIC Leader
Rebecca D. Kush, PhD, President and CEO, CDISC
© CDISC 2011
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World Standards Day
International
standards
Creating
CONFIDENCE
Globally
14
October
2011
© CDISC 2011
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CDISC Vision: Informing patient
care and safety through higher
quality medical research
© CDISC 2011
CDISC Strategic Goals 2012 ~ 2015
# 1 Core Standards for Aggregate Data Analysis
• Achieve significant progress in the use of core
CDISC standards to allow scientifically sound data
aggregation and support secondary uses of
research data for the purposes of scientific
investigation and comparative effectiveness.
Examples:
• FDA and NCI are developing a Clinical Trial Repository
(CTR); the model will be open. It is based on BRIDG and
SDTM.
• Critical Path Institute is developing open, shared databases
through Coalition Against Major Diseases (CAMD); based
on SDTM, developing CDASH.
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Public Release of Alzheimer's Clinical Trial Data By
Pharmaceutical Researchers
PR Newswire
WASHINGTON, 11 June 2010
First Combined Pharmaceutical Trial Data on Neuro-degenerative
Diseases; Shared Resource from Unique Public-Private
Partnership Will Help Accelerate Alzheimer's, Parkinson's, and
Other Brain Disease Research
WASHINGTON, June 11 /PRNewswire-USNewswire/ -- A new
database of more than 4,000 Alzheimer's disease patients who
have participated in 11 industry-sponsored clinical trials will be
released today by the Coalition Against Major Diseases
(CAMD). This is the first database of combined clinical trials to be
openly shared by pharmaceutical companies and made available to
qualified researchers around the world.
Initial database required mapping to a
standard (CDISC); can now be leveraged
to collect data using the standard.
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CDISC Strategic Goals 2012 ~ 2015
# 2 Healthcare/Research Data Interoperability
• Achieve significant progress in enabling
interoperability between clinical care and clinical
research, and explore expansion from bench to
bedside
• By linking these realms through standards, CDISC
will follow its principle of collecting data once,
using it many times, so that research informs
healthcare, and healthcare informs research.
Examples:
• CDISC-IHE Integration Profiles, e.g. RFD
• EHR for Clinical Research Functional Profile
• IMI EHR4CR and Interoperability Showcases
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CDISC Strategic Goals 2012 ~ 2015
# 3 Semantics
• Develop CDISC SHARE, a global, accessible,
electronic library for CDISC content.
• CDISC SHARE will enable precise and
standardized data element definitions and richer
metadata that can be reused within applications
and across studies to improve biomedical
research and its link with healthcare.
Examples:
• SHARE = Shared Health and Research Electronic Library;
stakeholder survey of > 70 participants agreed on value.
• Concepts for research developed; infrastructure ‘on hold’
due to NCI evaluation…seeking global solution.
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CDISC Strategic Goals 2012 ~ 2015
• # 4 Therapeutic/Specialty Area Standards
• Expedite the development and rollout of new
therapeutic-area or specialty standards while
continuing to refine, support and educate on
existing standards.
• Incorporating therapeutic area needs into existing
CDISC standards will ensure consistency in data
capture and analysis for therapeutic endpoints
and other disease-specific data elements to
address efficacy and other aspects of trials.
Examples: Alzheimer’s disease…..
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Now published….
CDISC Alzheimer’s Disease SDTM User Guide (Version 1.0) ©
© CDISC 2011
See also “Questionnaires” on the CDISC website
under Standards & Innovations.
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CDISC Strategic Goals 2012 ~ 2015
# 5 Ensure CDISC Infrastructure to Support the
first four goals!
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Standards Maintenance
Legal/HR/Accounting
Education
Alliances
Member Relations
Public Relations
 Communications
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Recent Lessons from the HIT
Standards Committee Chairs
• We need to balance innovation vs. specification; don’t ‘constrain’
but rather define what can be supported.
• Learn from others who have pushed the envelope.
• In many countries, developers cannot articulate a standard until
it is perfect; since it is never perfect, it is never articulated.
• One way of thinking of a definition for standards is that they are
‘implementable’ and that their success is measured by adoption
vs. volumes of documentation:
“Standards aren’t created; they are adopted.”
Quotes from HITSC Chairs,
Jonathan Perlin and John Halamka
CDISC Blog and eNews 7 October 2011
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CDISC Operational Direction
a) managing a robust, quality process that is far more
streamlined than the one we used for developing our core
standards;
b) thinking outside of the box in order to develop such a
process and accompanying tools such as SHARE;
c) linking our work with healthcare and genomics standards;
d) re-engaging our CDISC volunteers and engaging new
volunteers from around the globe;
e) not expecting a perfectly complete standard before it is
made available for comment, testing, iteration,
improvement and gradually broader adoption;
f) build upon our core standards;
g) increase adoption.
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