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    Investigating the Use of FHIR in Clinical Research

      Investigating the Use of FHIR in Clinical Research

      Oct 01, 2025

      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

      Alex Pearce, PHUSE Project Assistant 

      alexandra@phuse.global

      CURRENT STATUS (Updated Quarterly) 

      • ​Based on our discussions with the Clinical Decision Support Group, we elected to defer the ballot to develop a new approach (not bound to expectations around base capabilities of an EHR system)
      • Developing content in line with new assumptions to support clinical research activity scheduling​
      • Regularly meeting with Clinical Decision Support and Structured Data Capture teams to verify assumptions and develop extensions to add to updated Implementation Guide​
      • Aiming for updated IG Q1 2026​

      Objectives & Deliverables

      Timelines

      Begin work on two new Use Cases Q2 2023 
      Continue to identify opportunities for presenting and recruitingQ2 2023
      Published DeliverablesDate
      Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API2018

      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

      • HL7 Vulcan 
      • HL7 Biomedical Research and Regulatory (BR&R) 
      • CDISC to FHIR Joint Mapping IG 

      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.
      , multiple selections available,
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