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Converting ClinicalTrials.gov records to FHIR Resources

Vulcan Implementation Showcase

April 28, 2022

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Brian S. Alper, MD, MSPH, FAAFP, FAMIA

CEO, Computable Publishing LLC

President, Scientific Knowledge Accelerator Foundation

Project Lead, EBMonFHIR

balper@computablepublishing.com

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https://docs.google.com/presentation/d/17tW7uPOK3lksD70ly7bXkISSxpij3mIs

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Pictorial Agenda

  • Image of structured data in ClinicalTrials.gov schema
  • Image of FHIR specification
  • Image of transformed data on the Fast Evidence Interoperability Resources (FEvIR) Platform at https://fevir.net/

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eligibility 0..1 Reference (Group | EvidenceVariable)

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Instructions how to convert a ClinicalTrials.gov record to FHIR

  • 1. Go to https://fevir.net/ctgovconvert
  • 2. Enter the NCT ID
  • 3. Click the Submit button

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Additional Items

Added 2022-05-11

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Next Steps for ClinicalTrials.gov Conversion

  • Revise the handling of sites with recruitment status (see next slide)
  • Map the updated schema at https://beta.clinicaltrials.gov/
    • Addition of dateTime format
    • Addition of geoLocation data for research sites
  • Revise the converter to updated schema
  • Provide API to support FHIR export at https://beta.clinicaltrials.gov/

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TODO items for ResearchStudy Resource

  • 1. Publish ResearchStudyPartyRole code system/value set
    • for ResearchStudy.associatedParty.role
  • 2. Publish updates to ResearchStudyStatus code system/value set
    • For ResearchStudy.currentState
  • 3. Solve the model for status for a site
    • Will be able to replace the use of an extension once solved
    • Current suggestion is to create a ResearchStudy Resource for each site:
      • ResearchStudy.partOf {Reference ResearchStudy}
      • ResearchStudy.site {Reference Organization}
      • ResearchStudy.currentState (CodeableConcept)

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