Investigating the Use of FHIR in Clinical Research

Project Description

Interest in eSource continues to highlight the persistent challenge of integrating data between research systems (e.g. EDC, CTMS, CDMS) and healthcare systems (e.g. EHRs). Despite repeated efforts, scalable and widely adopted solutions have not been achieved. Historically, concerns have centred on the perceived limitations of healthcare data quality for research, slow and costly adoption of electronic systems at investigative sites, and a focus on operational rather than clinical data capture. Additionally, implementation of required interfaces has been resource-intensive, and the lack of a universally supported electronic exchange standard has created fragmentation.

However, these barriers are gradually being addressed. Government initiatives have accelerated the adoption and accessibility of electronic health records, while industry collaborations are prioritising the integration of healthcare data into research. Notable efforts include the TransCelerate eSource Initiative and the HL7 Vulcan Accelerator, both aiming to support more efficient and standardised data exchange.

Geoff Low, Medidata Solutions

geoff.low@3ds.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global

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.

Published Deliverables

Date

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

2018

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.