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CDISC Essential Standards to Enable Learning (ESTEL) · PDF file 30/05/2014  · Activities to Date Relative to ESTEL •May 2012 – Learning Health Community Summit •Q4 2013 –

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  • © CDISC 2014 1

    CDISC Essential Standards to Enable

    Learning (ESTEL)

    Rebecca D. Kush, PhD

    President and CEO

    IOM Digital Learning Collaborative: EHRs and Research

    30 May 2014

  • © CDISC 2012

    Research findings to inform

    healthcare decisions

    Information from healthcare (private, aggregated)

    to enable research

    •Discovery of new therapies •Understanding diseases •Testing/comparing therapies (CER) •Assessing efficacy •Monitoring safety •Understanding responses (genomics, biomarkers) •Public health/quality evaluations •Post-marketing surveillance

    •Quality healthcare •Informed decisions •Personalized medicine •Patient safety and privacy •Public health •Improved therapies •Efficiencies/reduced costs

    Research Healthcare



    ~17-year cycle

  • A National-Scale Learning Health System:

    Background from the Institute of Medicine

    of the National Academies

  • © CDISC 2014

    National LHS: One Infrastructure that Supports • Research

     Clinical

     Comparative effectiveness

     Translational

    • Public Health

     Surveillance

     Situational Awareness

    • Quality Improvement

     Health process and outcomes


     Best practice dissemination

    • Consumer Engagement

     Knowledge-driven decision making

    Source: Dr. Charles Friedman

  • © CDISC 2014

    Learning Health Community

    • Infrastructure can enable

    necessary virtuous cycle of

    study, learning and


    • This requires assembly of data,

    analysis, and feedback

    Assemble Change


    Analyze Feedback


    • Person-focused

    • Privacy

    • Inclusiveness

    • Transparency

    • Accessibility

    • Governance

    • Cooperative and

    Participatory Leadership

    • Scientific Integrity

    • Value

  • © CDISC 2014


  • © CDISC 2014

    The Learning Health Community

    • Grew out of the 2012 “Learning Health Summit”

    • A self-organizing, multi-stakeholder coalition of the willing

    • 60 “endorsers” plus > 600 others expressing interest

    • “Summit” Planning Committee became the Community’s

    Coordinating Committee

    • Catalyzing, leading, and participating in initiatives to

    realize a Learning Health System

    - Standards (ESTEL)

    - Governance

    - Technology

  • © CDISC 2012

    Essential Standards to Enable

    Learning (ESTEL) Charter

    Purpose and Scope:

    To define a parsimonious/essential/minimum core set of

    standards that could enable a standards-based yet flexible and

    scalable LHS in accordance with the following goals:

    • a) Ease the burden for any clinician to participate in a research

    study or other learning activity;

    • b) Increase the capacity for learning from data;

    • c) Obtain knowledge and results in an actionable form to

    contribute to building the LHS;

    • d) Ensure that the data obtained can be readily aggregated

    and/or compared; and

    • e) Ensure that the data uphold scientific integrity.


    ~ December 2012

  • © CDISC 2012

    Activities to Date Relative to ESTEL

    • May 2012 – Learning Health Community Summit

    • Q4 2013 – ESTEL Name and Charter

    • February 2013 – ESTEL Launch @ CDISC Office

    • March 2013 – ESTEL Webinar

    • July 2013 – ESTEL “Exec” Group @ IOM

    • September 2013 – Second ESTEL F2F @ Duke

    • Oct 2013 – March 2014 - Teleconferences

    • April 2014 – Third ESTEL F2F @ AHRQ


  • © CDISC 2012

    Opportunities/Initiatives to Inform ESTEL

    • eSource Data Interchange (eSDI) Initiative – defined

    requirements (12) for using eSource (i.e. entering data

    electronically - including EHRs, eDiaries) in regulated

    research studies (~2006)

    • eSource Guidance released by EMA (2010) and FDA


    • CDISC Healthcare Link Initiative; IHE QRPH Group

    • U.S. Health and Human Services (HHS/ONC) HITSP

    Interoperability Specification – IS#158 (2009-2010)

    • HHS/ONC) Structured Data Capture (SDC) Initiative


    • EU Innovative Medicines Initiative (IMI) EHR4CR and



  • © 2012

    ASTER (AE Reporting from EHRs)

    30 Ambulatory care physicians at Harvard

    and Brigham and Women’s

    with Pfizer, CDISC, CRIX

    Nov 08 – Jun 09, > 200 Reports Sent to FDA

    Physician Reporting:

    *91% of participating physicians had

    submitted no ADE reports in the prior year

    *During the study, participants reported an

    average of approximately 5 reports in a 3

    month time period

    *All participants reported at least 1 AD

    * Process: Time to report decreased from

    ~35 min to < 1 min

    Source: Michael Ibara, Pfizer

  • © CDISC 2012

    The “S” Word

    What is a standard? • A reference to quality

    • An average cut of beef

    • In the world of data and technology, there are ‘so many to

    choose from’! And, there are many types of standards.

     A standard is NOT proprietary.

     A standard is NOT a “one-off”.

     Standards are developed through a robust, authorized,

    consensus-based process and maintained by a

    recognized standards development organization (SDO).

     True standards are mature, useful and broadly adopted.

     Standards do NOT inhibit creativity, rather encourage




    ESTEL Launch – February 2013

  • © CDISC 2012

    Standards and the Learning Health System





    Tool Innovation

    The Whole System is

    Chaordic, Unmanaged,

    approaching Ultra-Large Scale

    The Essential Standards

    lie between the

    Whole System and the Tooling

    The Tools come from a


    Innovation Marketplace

    ESTEL Exec Group – July 2013

  • © CDISC 2012

    The Hourglass Model

    The narrow neck of the hourglass defines

    a small set of core abstractions and

    protocols (e.g. TCP and HTTP) onto

    which many different high-level behaviors

    can be mapped (the top of the

    hourglass), and which themselves can be

    mapped onto many different underlying

    technologies (the base of the hourglass).

    By definition the number of protocols

    defined at the neck must be small.

    The Anatomy of the Grid, Kesselman


  • 15

    The Neck Resource & connectivity


    The Collective “A wide range of global services

    and application-specific


    Fabric “Diverse range of resource




    Healthcare Data

    The Hourglass Model: LHS-ESTEL


    ESTEL Meeting – September 2013

    April 2014 ESTEL Meeting: Discussed

    Standards Requirements and ‘Who?’, ‘What?’

    and ‘How?’ relative to the Hourglass Model.

    Next Step: What are the Essential Standards

    for the LHS---Quality, Research, Public Health,

    Consumer Engagement?

  • © CDISC 2014

    TODAY: Research and Healthcare





    Paper or


    Healthcare Delivery Medical Research





    Data re-entry/transcription

  • © CDISC 2014

    CDISC Healthcare Link

    Goal: Optimize the Process


    Reconciliation for

    Source Data Verification

    (e)CRFs Source




    Healthcare Delivery


    Medical Research

  • © CDISC 2014

    Leveraging Existing Standards at the

    Intersection of Healthcare and Research

    • Standards FIT FOR PURPOSE, working together


    • Biomedical Research Integrated Domain Group Model

    (BRIDG) (2003-Present)  Collaborative, with key stakeholders: NCI, CDISC, HL7, FDA


    • IHE Profiles for Clinical Research – CDISC Healthcare Link

     Developed through the Quality, Research and Public Health (QRPH)

    Group with CDISC Leadership

     Include Retrieve Form for Data Capture RFD), Research Matching (RM),

    Retrieve Process (Protocol) for Execution (RPE), Data Excha

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