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 Leads	Email
Geoff Low, Medidata Solutions	geoff.low@3ds.com
Nicola Newton, PHUSE Project Assistant	nicky@phuse.global

CURRENT STATUS Q1 2025

No update.

Objectives & Deliverables	Timelines
Begin work on two new Use Cases	Q2 2023
Continue to identify opportunities for presenting and recruiting	Q2 2023

Published Deliverables	Date
Use of HL7 FHIR as eSource to Pre-populate CDASH Case Report Forms Using a CDISC ODM API	2018

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.

Project Scope

Objectives & Deliverables

Timelines