CDISC Standards around the World

CDISC Standards around the World
Bron Kisler & Rhonda Facile
Genetic Alliance, 9 September 2014
© CDISC 2014
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Outline
•  Overview of CDISC
•  Therapeutic Area Standards
•  SHARE Metadata Repository
•  Healthcare Link
•  Wrap Up / Q&A
© CDISC 2014
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What is CDISC?
Clinical Data Interchange Standards Consortium
Global Standards Development Organization (SDO)
Founded in 1997 (all volunteers)
Incorporated in 2000 as a non-profit organization
Over 320 member organizations
90 countries; Coordinating Committees in Europe,
Japan, China, Asia-Pacific; 20 user networks
  Robust education program
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Mission: To develop and support global, platform-independent data standards
that enable information system interoperability to improve medical research and
related areas of healthcare
© CDISC 2014
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CDISC has established worldwide industry standards to
support the electronic acquisition, exchange,
submission and archiving of clinical research data and
metadata to improve data quality and streamline medical and
biopharmaceutical product development and research
processes
Consensus-based development
Standards are freely available at www.cdisc.org
IP Policy ensures open standards
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© CDISC 2014
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CDISC Around the Globe
2010
2001
2000
2008
2002
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© CDISC 2014
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EU - Innovative Medicines Initiative:
Joining Forces in the Healthcare Sector
The biggest public/private partnership in Life Science aiming to: •  Make drug R&D processes in Europe more innova8ve and efficient •  Enhance Europe’s compe88veness •  Address key societal challenges Features: •  1:1 funding, joint decision making All EU funds go to SMEs, academia, paBent •  organisaBons and regulatory agencies •  Large pharmaceuBcal industry, represented by EFPIA, contributes in-­‐kind Ann Martin, Principal Scientific Manager, IMI Knowledge Management
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CDISC and IMI
•  IMI is a member of CDISC
•  CDISC and IMI have a Memorandum of Understanding
•  …identify and engage in areas of mutual research interest
primarily around IMI Knowledge Management; CDISC education
and training
•  CDISC established the CDISC Europe Foundation (CEF)
to participate in European Commission funded projects
•  CDISC is a partner on 3 IMI projects
•  eTRIKS – European Translational Information & Knowledge
Management Services, using TranSMART platform
•  EHR4CR – Electronic Health Records for Clinical Research
•  BioVacSafe – Vaccine Safety
© CDISC 2014
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http://www.pmda.go.jp/english/service/pdf/taskforce/140620-tsuchi_e.pdf
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http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm368613.htm
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PDUFA Goals - Section XII
•  Clinical Terminology Standards: Using a public process
that allows for stakeholder input, FDA shall develop
standardized clinical data terminology through open
standards organizations (i.e., CDISC) …
−  … FDA published version 2.0 of the Therapeutic Area Standards
Initiative Project Plan June 2014
•  …periodically publish final guidance specifying the
completed data standards, formats, and terminologies
that sponsors must use to submit data in applications.
Source: Ron Fitzmartin, FDA CDER, Office of Strategic Programs
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Therapeutic Area Standards
© CDISC 2014
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Coalition For Accelerating Standards & Therapies
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Formed by CDISC and the Critical Path Institute (C-Path)
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A joint initiative to accelerate clinical research and medical
product development by creating and maintaining data
standards, tools and methods for conducting research in
therapeutic areas that are important to public health
• 
With the enactment of FDASIA/PDUFA V, FDA recognized the
opportunity to work with CFAST, along with the pharmaceutical
industry, to develop therapeutic area data standards.
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CFAST Steering & Advisory Members:
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Current and Planned CFAST Projects
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© CDISC 2014
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Collaborations & Governance
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CFAST SAC
CFAST TAPSC
Scientific Advisory Committee
Therapeutic Area Program
Steering Committee
Provides Scientific Advice to TAPSC
Identifies Risks and Opportunities
Identifies/Engages Relevant Partners
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Prioritizes/Approves Proposals
Approves Projects & Charters
Resources & Oversees Projects
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How is CFAST Different?
•  Enhanced development process to address the
requirements of TA concept development
•  Focus on research and clinical input early in the
process
•  The use of public database searches
•  Attention to medical literature and regulatory
guidance (reference management)
•  Use of Concept mapping
•  Availability of Dedicated resource
•  Committed CFAST community
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Therapeutic Area Standards –
Baseline Content
•  Mindmap/model of disease area clinical concepts
•  Essential core data elements with definitions, data types
(simple & ISO 21090), BRIDG and SDTM mappings
  Core = most common
•  SDTM domains and examples
•  Minimum terminology value sets (from code lists) with
definitions and C-Codes
•  User/Implementation Guide with permissions statements
•  CDASH CRFs with SDTM annotations, as appropriate
•  ADaM analysis models
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CFAST as a Convergence Catalyst
•  The process of developing TA concepts has
caused a convergence effect
SDTM
BRIDG
Terminology
TAUG
CDISC SHARE
ADaM
CDASH
TAUG - Therapeutic Area User Guide
© CDISC 2014
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SHARE Metadata Repository
© CDISC 2014
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Global electronic repository for developing, integrating
and accessing CDISC standards metadata in
electronic format.
SHARE should dramatically improve the quality,
reusability and integration across CDISC standards
and controlled terminologies, and improve
interoperability with healthcare.
SHARE is the foundation for standards-based automation,
which is critical to maximizing the Return on Investment of
implementing standards
© CDISC 2012
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Research Concepts and Metadata:
The Keys to End-to-End Standards
Define Once; Use Many Times
Research Concept-Based Standards Development
(e.g., Waist Measurement)
Defined
Observations
Performed
Observations
Performed
Results
+Derived
Results
Protocol
PRM, SDMXML
CRF
Collection
CDASH
Data
Tabulations
SDTM
Analysis
Datasets
ADaM
Data Reviewers
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User Perspectives of SHARE
SHARE
iSHARE
eSHARE
(SHARE Interactive)
(SHARE Exports)
Standards Development
& Governance
© CDISC 2012
Accessing Published Standards
in a Machine-Readable Format
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© CDISC 2012
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CDISC Healthcare Link
© CDISC 2012
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© CDISC 2014
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CDISC ‘Healthcare Link’ Initiative:
Optimizing the Process
Healthcare Delivery
Source
Documents
EHR
Medical Research
eSource
(e)CRFs
Auto
Reconciliation for
Source Data Verification
© CDISC 2014
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Leverage Synergistic Standards
Healthcare Delivery
eSource
Documents
EHR
Medical Research
Integration
Profiles
(e.g. RFD)
ODM
eCRFs
HL7 CCDA
2014
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Wrap Up / Q&A
© CDISC 2012
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Key Messages
•  Standards streamline research processes from eSource through
reporting/submission, while allowing innovation and creativity.
•  CDISC has a full complement of research standards, from Protocol
(and EHRs) through Analysis and Reporting.
•  The greatest benefits are reaped when CDISC standards are used
from the start of the research project (build quality in at the
beginning).
•  The therapeutic area standards will augment/complete the CDISC
Foundational Standards.
•  The best standards result from having the most global input during
their development – please join in and get involved with CDISC!
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CDISC Communications
•  Website Upgraded in June
www.cdisc.org
CDISC 2013 Annual Report
•  New Business Case to be available
September 2014
•  YouTube Videos e.g. SHARE
https://www.youtube.com/watch?
v=gCyVdvgVpY8
•  Press Releases & Announcements
•  eNewsletter-New Format
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Questions?
Strength through collaboration…
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