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. 2021 Jan 12;9(1):e20470.
doi: 10.2196/20470.

Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study

Christian Gulden  1 , Romina Blasini  2 , Azadeh Nassirian  3 , Alexandra Stein  4 , Fatma Betül Altun  5 , Melanie Kirchner  6 , Hans-Ulrich Prokosch  1   6 , Martin Boeker  7
Affiliations

Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study

Christian Gulden et al. JMIR Med Inform. .

Abstract

Background: Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that the same studies often need to be registered in different registries with different data entry requirements and interfaces.

Objective: This study investigates how Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records.

Methods: We designed and prototypically implemented an open-source central trial registry containing records from university hospitals, which are automatically exported and updated by local study management systems.

Results: We provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format.

Conclusions: The results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.

Keywords: HL7 FHIR; clinical trials; data sharing; health information interoperability; trials registry.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Flowchart showing the different phases of implementing the multisite Fast Healthcare Interoperability Resources (FHIR)-based trial registry.
Figure 2
Figure 2
Unified Modeling Language (UML) diagram showing the set of identified data elements in the context of a trial registry.
Figure 3
Figure 3
Architecture of the Fast Healthcare Interoperability Resource (FHIR)-based trial registry.
Figure 4
Figure 4
Example of 6 exported records, 4 of which (A-D) refer to one multicentric study (NCT=1, DRKS=2, EudraCT=3), and 2 of which (E and F) refer to a different multicentric study (NCT=4, DRKS=5), represented as a table (left) and an undirected graph (right). These studies are merged into 2 master ResearchStudy resources, each with a distinct set of identifiers and participating sites (bottom).
Figure 5
Figure 5
The HTTP GET query sent to the Fast Healthcare Interoperability Resources (FHIR) server to retrieve all actively recruiting master studies.
See this image and copyright information in PMC

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