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Project Scope

Increasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with wide-scale adoption, for a variety of reasons.

Some common historical points of view have included:

  • That the quality of the data that can be retrieved from the Healthcare sites is insufficient to meet research needs.
  • That uptake of electronic systems at investigative sites has been slow, expensive, and not delivering real value to healthcare practises.
  • Types of data captured in healthcare have been more operational rather than clinical.
  • Enabling the Necessary interfaces is an expensive and process-heavy undertaking.
  • There is not a suitable, generally supported electronic exchange format, with a number of standard representations being supported in recent memory.

Many of these issues are on the path to being resolved; government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator.



Project LeadsEmail

Geoff Low (Medidata Solutions)

geoff.low@3ds.com

Katie Warren (PHUSE Project Assistant)

katie@phuse.global


Objectives & Deliverables

Timelines

Begin work on 2 new use cases Q2 2023 
Continue to identify opportunities for presenting and recruitingQ2 2023


  • Presentation at the EU Connect 
    • IG in for Ballot

    Status
    colourBlue
    titleCurrent Status
     Q3/4 2022 

    Q1 2023

    • HL7 IG  successfully balloted 
    • Good representation at the EuroVulcan event 


    Published DeliverablesDate
    Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API2018



    Project Members

    Organisation

    Aditya GadikoMMS 
    Andy RichardsonZenetar
    Anupama SheoranBayer
    Bala Nair CRIO 
    Barbara BlockleyIndustry
    Bibek Bhattacharya IgniteData
    Dan LiSanofi
    Dan Newingham ZS
    Dave Iberson-HurstCDISC
    Denzin CoskunIndustry
    Ergin Soysal Eli Lilly 
    Greg JonesOracle Health Sciences
    Hugh GloverBlue Wave Informatics
    Ingeborg HoltIBM



    Project MembersOrganisation
    Jeff AbolafiaPinnacle 21
    John Owen CDISC
    Jozef AertsXML4Pharma
    Michael WardEli Lilly
    Mike HamidiPfizer
    Mitch MaysEli Lilly
    Raj SodhiAmgen
    Ramaiah MuvvalaInductive Quotient Analytics
    Rasesh PatelEli Lilly
    Rebecca BakerCDISC
    Rahul ThandavanRoche
    Rasesh Patel Eli Lilly
    Richard Yeatman IgniteData
    Ron Sweeney Integration Required
    Shani Sampson TransCelerate BioPharma Inc
    Simon Treliving IgniteData 
    Stacy TeganTransCelerate BioPharma Inc 
    Warda SaeedEli Lilly



    Recommended Solutions

    • The FHIR resource-based view of healthcare data is much more aligned to the research 'view' of data; research considers study using CRFs, artificially aligned with clinical data element domains. In the future, these two views of the same data will be more closely aligned from capture through to submission. There is a need for external activities to assist in this alignment (such as mapping to or extending of submission formats, alternative data management processes, focus on the lifecycle of a datapoint, etc). These tasks should be solved in a pre-competitive manner and shared with all stakeholders.
    • Increasing government engagement in personal healthcare data has focussed on the need for seamless exchange (including access, consent, format, understandability, etc). Most guidance has recognised that the technology is a key foundation and have chosen FHIR as their preferred format. This is an initiative that the research industry can leverage to more closely engage with the participants in clinical research.



    Stakeholders/Initiatives

    Specific Actions

    • Identify gaps and opportunities between the Healthcare and Research realms with a view to providing a shared vocabulary and platform to enable better collaboration.
    • Prepare White Papers for Biopharmaceutical Companies providing sample use cases for where the adoption of FHIR will improve the experience of Sponsors, Technology firms and most importantly sites and site users.
    • Work with stakeholders to socialise and formalise (e.g. through HL7 FHIR Profiles/Implementation Guides) the technology/approach.