Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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.

PubMed Disclaimer

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

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on Trial Registration 11 Years after the ICMJE Policy Was Established. N Engl J Med. 2017 Jan 26;376(4):383–391. doi: 10.1056/nejmsr1601330. - DOI - PMC - PubMed
    1. Baudard M, Yavchitz A, Ravaud P, Perrodeau E, Boutron I. Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses. BMJ. 2017 Feb 17;356:j448. doi: 10.1136/bmj.j448. http://www.bmj.com/lookup/pmidlookup?view=long&pmid=28213479 - DOI - PMC - PubMed
    1. De Oliveira GS, Jung MJ, McCarthy RJ. Discrepancies Between Randomized Controlled Trial Registry Entries and Content of Corresponding Manuscripts Reported in Anesthesiology Journals. Anesthesia & Analgesia. 2015;121(4):1030–1033. doi: 10.1213/ane.0000000000000824. - DOI - PubMed
    1. Adam GP, Springs S, Trikalinos T, Williams JW, Eaton JL, Von Isenburg M, Gierisch JM, Wilson LM, Robinson KA, Viswanathan M, Middleton JC, Forman-Hoffman VL, Berliner E, Kaplan RM. Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series. Syst Rev. 2018 Apr 16;7(1):59. doi: 10.1186/s13643-018-0726-5. https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s136... - DOI - DOI - PMC - PubMed
    1. Dickersin K, Rennie Drummond. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA. 2012 May 02;307(17):1861–4. doi: 10.1001/jama.2012.4230. - DOI - PubMed

LinkOut - more resources