AMIA Clinical Trial Working Group 14 November 2006

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AMIA Clinical Trial Working Group14 November
2006

• Rebecca D. Kush, PhD
• President CEO, CDISC

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Clinical Data Interchange Standards Consortium
(CDISC)

• Global, open, multidisciplinary, non-profit
  organization initiated in 1997 as a volunteer
  organization.
• Incorporated in 2000 now gt 175 member
  corporations (including biopharmaceutical
  companies, technology and service providers,
  IRBs, academia.)
• Established groups in Europe and Japan.
• Through a consensus-based approach, CDISC has
  established worldwide industry standards to
  support the electronic acquisition, exchange,
  submission and archiving of clinical trials data
  and metadata to support clinical research.
• More information at www.cdisc.org

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• The mission of CDISC is to develop and support
  global,
• platform-independent data standards that enable
  information system interoperability
• to improve medical research and related areas of
  healthcare.

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EFPIA PhRMA

• Submission Standards
• ODM eSDI
• Protocol Representation
• Critical Path Initiative

• Shared Information
• Business Case
• IA Project
• CDASH
• eSubmissions

WHO International Clinical Trial Registry
Platform CDISC ODM

• Protocol Representation w/
• elements mapped to EudraCT
• Interest in BRIDG AE Modeling
• ODM for archive

• Terminology Production
• Clinical Trial / Lab Stds
• BRIDG

NIH / DCRI

• Protocol Representation
• Terminology
• LAB Model
• BRIDG

• Liaison Status to ISO/TAG215
• Submitted CDISC Standard
• as New Work Item

HIMSS

• Data Collection Standards
• (Critical Path Initiative)

• Integraton Profile
• Healthcare Link Demo

CV and TB Standards
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Terminology Collaboration ? Harmonization
The BRIDG Model

• A clinical research domain analysis model
  initiated by CDISC,
• BRIDGing
• Organizations (CDISC, HL7, FDA, NCI.)
• Standards
• Research and Healthcare

• Biomedical Research Integrated Domain Group
  (BRIDG) Model

RCRIM
EVS NCI Enterprise Vocabulary Services
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eSDI and HIT

• Purpose of eSDI Initiative
• to facilitate the use of electronic technology in
  the context of existing regulations for the
  collection of eSource data in clinical trials for
  regulatory submission by leveraging the power of
  the CDISC standards, in particular the
  Operational Data Model (ODM).
• Note eSource pertains to eDiaries, ePRO, eDCI,
  Electronic Health Records
• eSDI Group
• Representatives from academic research
  organizations, pharma, CROs, validation experts,
  technology providers 5 FDA liaisons
• eSDI Document
• Includes 12 requirements for eSource
• Describes 5 possible scenarios (3 Electronic
  Health Records)
• Posted for Open Public Review and Comment by 17
  October
• Over 500 comments received on first open review
  and 150 on second review currently updating
• Plan to post final Version 1.0 soon
  (www.cdisc.org)

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Collaborative Group Participant Organizations (15)
Data Collection Standards FDA Critical Path
Initiative

• National Institutes of Health (NIH) whose
  participation is being coordinated through the
  Clinical Research Policy Analysis and
  Coordination Program
• Pharmaceutical Research Manufacturers Association
  (PhRMA)
• American Medical Informatics Association (AMIA),
  especially the Clinical Trials Working Group
• Critical Path Institute (C-PATH)
• National Clinical Research Resources (NCRR)
• Clinical Research Forum
• Baylor College of Medicine
• Society of Clinical Data Management (SCDM)
• National Library of Medicine (NLM)
• National Cancer Institute (NCI)
• Biotechnology Industry Organization (BIO)
• Association of Clinical Research Professionals
  (ACRP)
• Association of Clinical Research Organizations
  (ACRO)
• Food and Drug Administration (FDA)
• Clinical Data Interchange Standards Consortium
  (CDISC)

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HIT - Healthcare Link
Patient Care World
Clinical Research World
An industry initiative that has successfully
demonstrated clinical information
interoperability between physician clinical
systems (EHR) and pharmaceutical clinical trials
systems based on open standards (HL7 and CDISC).

CDISC Healthcare Link Initiative Building upon
Single Source. Next Step Integration Profile
and Demo
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IHE Integration Profile and HIMSS
Interoperability Showcase

• Demo based on an IHE integration profile,
  Retrieve Form for Data-Capture (RFD).
• RFD allows a pharma sponsor to surface a
  data-capture form within an Electronic Health
  Record session.
• Simulate the use of RFD, ODM, and ICSR in support
  of life sciences
• Pharmaco-vigilance, sponsored by Pfizer
• Clinical trial execution, sponsored by Lilly
• Bio-surveillance, sponsored by SAIC
• Clinical trial labs and images, sponsored by
  Novartis
• Disease registry, sponsored by Genzyme
• Technical support from Digital Infuzion, SAS,
  Assero, Outcome, Phase Forward, and others.
• EHR and RHIO participation from Allscripts,
  Cerner, Siemens, IBM, Accenture and others.

• Integrating the Healthcare Enterprise
• Health Information Management Systems Society

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HIT - Healthcare Link Activities
CDISC is the standards link to healthcare
(Electronic Health Records) for the regulated
biopharmaceutical industry.

• eSource Data Interchange (eSDI) Document
• CDASH Initiative (Data Collection Standards)
• Proof of Concept, IHE Integration Profile and
  HIMSS Demo
• Participation in US Healthcare Information
  Technology Standards Panel (HITSP) and Board Seat
  on HITSP Promoting Use Case for Clinical
  Research
• Continued Work to Ensure Harmonization of CDISC
  Standards for Clinical Research with Healthcare
  Standards (HL7)
• BRIDG Modeling and Standards Harmonization
• Stressing Global Standards

Key goals are to facilitate clinical research for
investigators And increase access to safe new
therapies for patients.
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CDISC and AMIA CTWG

• 2006
• Jointly-sponsored Webinar Series
• HIT Letter (ACRO initiated)
• CDASH Collaborative Group
• DIA eClinical Workshop
• 2007 ? ideas
• IHE/HIMSS Demo
• Continue CDASH Initiative Support, Communication
  and Progress
• Additional Jointly-sponsored Educational
  Activities
• Global Trial Bank
• Other ideas?

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Vision Medical Innovation
Regulatory Authority
Data Sources
Public Registries and IRBs
EDC
EHR
CDISC Standards Real-time Integration
Rolling Warehousing, Reporting and Submissions
Subject Data Enter Once for Multiple Purposes
Sponsor
ECG X-RAY
CRO or Partner
LAB
Payer
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Opportunity 45. Data Collection
Standards

• An Opportunity of the FDA Critical Path
  Initiative
• Mission To develop a set of content standards
  (element name, definition, metadata) for a core
  set of global data collection fields that will
  support clinical research studies.
• Scope The initial scope will be the safety
  data/domains to support clinical trials.
• Project Leader Rhonda Facile (rfacile_at_cdisc.org)
  
• Initiated Collaborative Group to provide
  strategic direction and ensure organized, global
  strategy and resources.
• Named CDASH Clinical Data Acquisition Standards
  Harmonization
• Timeline Achieve initial scope by end of 2007

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• Knowing is not enough
• we must apply.
• Willing is not enough
• we must do.
• - Goethe-

To the gracious supporters who apply and do.
THANK YOU! Rebecca Kush rkush_at_cdisc.
org
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Information and Contacts

• For standards and information, see www.cdisc.org
• eNewsletters available via e-mail contact
  Shirley Williams swilliams_at_cdisc.org or sign up
  on the CDISC website.
• Technical questions Julie Evans jevans_at_cdisc.org
  or Public Discussion Forum
• Education and Membership Frank Newby
  fnewby_at_cdisc.org
• Rebecca Kush rkush_at_cdisc.org

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