CDISC MDR Market Positioning 0 3 by ME55CW

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									                                                              CDISC MDR
                                                              Market Positioning




                CDISC Meta data Repository
          Enrichment & integration of CDISC Data
        Standards toward semantic interoperability

                             Market Positioning

                    Prepared by the CDISC MDR Team




                                   Notice to Readers


        This is a working document prepared for the CDISC strategic committee who
         needs to define the guiding principles of governance.




Revision History


       Date        Version                    Summary of Changes

 Nov 08                      Initial version prepared by the business requirement
                             core team




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                                                 Table of Contents

1.   WHAT IS CMDR: ............................................................................................................................... 4
2.   VALUE PROPOSITION .................................................................................................................... 5
3.   EXPECTED MARKET PENETRATION......................................................................................... 6
4.   GOVERNANCE: GUIDING PRINCIPLES ..................................................................................... 7




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1. What is CMDR:

The data collected in clinical care and in clinical research, as well as in pre-clinical
research, can be captured and stored as a collection of concepts and variables. A
concept provides a definition of a particular piece of information together with a
link to the variables used to store the information.

      The CMDR is the repository of the definition of concepts and related
       variables
           o Concepts will be unambiguous as they inter-relate to context/other
               concepts through an information model (e.g. BRIDG) and through
               abstract data types (HL7/ISO abstract data types)
           o Variables will be unique (or there will be a "golden standard"
               variable to be used)
      The CMDR is based on linked/constrained controlled terminologies i.e. a
       findings like systolic blood pressure is related to body position, devices,
       target site.... not all values for body position make sense for Systolic blood
       pressure. These are implicit constraints across controlled terminologies that
       will be expressed explicitly in CMDR
      The CMDR will initially focus on clinical trial, epidemiology, HEOR and
       pharmacovigilance. In a second stage pre-clinical and research should be
       considered, as well as extension for medical devices and EHR integration.
       Within Clinical trials, the CMDR will encompass safety and efficacy data
       together with CDISC trial design data.




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2. Value proposition
   2.1 Background
Currently there are some sporadic, limited efforts at creating industry standard concepts
and variables e.g. the joint NIH/CDISC tuberculosis standard
Individual organizations (Pharma, CROs, institutions etc) typically use internal standards
(i.e. standards developed within individual organizations) though – in clinical trial space -
many are now moving to the use of SDTM and ADaM However SDTM and ADaM do not
provide a complete set of concepts and variables even for clinical research.
As a consequence, the ability to aggregate data and to share data is limited as data have to
be mapped to alternative standards. This impacts all organizations as well as impacting
patient safety.
The creation of the CMDR, populated with industry standard concepts and variables, will
address the shortfall enabling rapid evaluation of drug safety across company boundaries,
improving operational efficiency in the collection, processing and reporting of data and
enhancing scientific capability due to the dramatic increase in data reuse capability.


   2.2 Purpose of CMDR

There are 4 pillars for computer semantic interoperability: information model,
data type, controlled terminology and messages. CMDR is the computationally
tractable implementation of the first 3 pillars.

      CMDR will complement HL7 CDISC content messages with consistent
       definitions across the industry, ensuring data integration in JANUS.
      CMDR will support extract of SDTM view from the HL7 CDISC content
       message.
      CMDR will support consistency across the CDISC standards and enable
       mapping with other non CDISC standards in clinical domain (e.g. other
       HL7 standards) by defining a "golden" standard database to which other
       standards can be mapped

CMDR will be needed by sponsors/CROs and by FDA/regulators. When extending
to EHR it will be needed by clinical care providers, including payers.




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3. Expected Market penetration
       Maximal scenario (not included in simulation in graph below): all sponsors will
        use CMDR for internal data curation/data integration

       Minimal scenario - related to regulatory requirements. As CMDR will be a key
        component of the HL7 CDISC messages, all companies will need to "synchronize"
        with CMDR. Based on this scenario, below is a simulation of CMDR in relationship
        with the evolution of SDTM submission with SAS transport file and HL7 CDISC
        content message. The actual numbers and dates are guesses but the trend is
        correct.


                                         CDISC Standards evolution



                                                                           SDTM training & structure
      Utilization




                                                                           SDTM in SAS transport file
                                                                           HL7 CDISC message
                                                                           CDISC MDR



                    2008   2009   2010   2011    2012   2013   2014
                                         Years




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4. Governance: guiding principles
(to be done by strategic committee)

Question                                    Answer
What should be the role of CDISC in CMDR     Owner
                                             Certification authority
                                             Responsible Maintenance organisation
                                             ……
If CDISC is not the owner, who should own   The responsible maintenance organization
the CMDR (tool and content) and how does    – which should be “accredited” (how do we
CDISC communicate with the “owner”          do this ?) by CDISC
                                            If we do “accreditation” should we go as
                                            well through CCHIT / Eurorec – how/who
                                            defines accreditation criteria
Who are our partners for the pilot phase         tool: NCI
   Tools                                        Content delivered by 3 to 5 pharma
   content                                         company willing to invest time of
                                                    their staff
Who should be our partner for the                Tool: RFP to an external company
definitive solution                                 with clear selection process and
    Tools                                          evaluation criteria
    Content                                     Content: ? responsibility of selected
                                                    organisation or pharma companies ?
How do we fund this                          Private investment (as part of RFP)
                                             CDISC own money
                                             European Commission (FP7 or specific
                                                money for semantic interoperability –
                                                would required extension to HER)
How/when do we extend it to HC                  
How do we communicate to CDISC                  
stakeholders these decision




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