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

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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.

Related collections

Most cited references 42

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Observational Health Data Sciences and Informatics (OHDSI): Opportunities for Observational Researchers.

George Hripcsak, Jon D Duke, Nigam Shah … (2015)

The vision of creating accessible, reliable clinical evidence by accessing the clincial experience of hundreds of millions of patients across the globe is a reality. Observational Health Data Sciences and Informatics (OHDSI) has built on learnings from the Observational Medical Outcomes Partnership to turn methods research and insights into a suite of applications and exploration tools that move the field closer to the ultimate goal of generating evidence about all aspects of healthcare to serve the needs of patients, clinicians and all other decision-makers around the world.

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SMART on FHIR: a standards-based, interoperable apps platform for electronic health records

Joshua C Mandel, David Kreda, Kenneth Mandl … (2016)

Objective In early 2010, Harvard Medical School and Boston Children’s Hospital began an interoperability project with the distinctive goal of developing a platform to enable medical applications to be written once and run unmodified across different healthcare IT systems. The project was called Substitutable Medical Applications and Reusable Technologies (SMART). Methods We adopted contemporary web standards for application programming interface transport, authorization, and user interface, and standard medical terminologies for coded data. In our initial design, we created our own openly licensed clinical data models to enforce consistency and simplicity. During the second half of 2013, we updated SMART to take advantage of the clinical data models and the application-programming interface described in a new, openly licensed Health Level Seven draft standard called Fast Health Interoperability Resources (FHIR). Signaling our adoption of the emerging FHIR standard, we called the new platform SMART on FHIR. Results We introduced the SMART on FHIR platform with a demonstration that included several commercial healthcare IT vendors and app developers showcasing prototypes at the Health Information Management Systems Society conference in February 2014. This established the feasibility of SMART on FHIR, while highlighting the need for commonly accepted pragmatic constraints on the base FHIR specification. Conclusion In this paper, we describe the creation of SMART on FHIR, relate the experience of the vendors and developers who built SMART on FHIR prototypes, and discuss some challenges in going from early industry prototyping to industry-wide production use.

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Update on Trial Registration 11 Years after the ICMJE Policy Was Established.

Deborah Zarin, Tony Tse, Rebecca J Williams … (2017)

In the decade following the journal editors’ trial registration policy, a global trial reporting system (TRS) has arisen to supplement journal publication by increasing the transparency and accountability of the clinical research enterprise (CRE), which ultimately advances evidence-based medicine. Trial registration a foundation component of the TRS. In this article, we assess impact of the trial registration on the CRE with respect to two key goals: (1) establishing a publicly accessible and structured public record of all trials and (2) ensuring access to date-stamped protocol details that change during a study. After characterizing international trial registry landscape, we summarize the published evidence of the impact of the registration laws and policies on the CRE to date. We present three analyses using ClinicalTrials.gov registration data to illustrate approaches for assessing and monitoring the TRS: (1) timing of registration (i.e., prior to trial initiation [prospective] or after trial initiation [retrospective or “late”]; (2) degree of specificity and consistency of registered primary outcome measures compared to descriptions in study protocols and published articles; and (3) a survey of the published literature to characterize how ClinicalTrials.gov data has been used in research on the CRE. These findings suggest that, while the TRS is largely moving towards goals, key stakeholders need to do more in the next decade.

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Author and article information

Contributors

Christian Gulden:

ORCID: https://orcid.org/0000-0003-1261-3691

Chair of Medical InformaticsDepartment of Medical Informatics, Biometrics and EpidemiologyFriedrich-Alexander University Erlangen-NürnbergWetterkreuz 15Erlangen, 91058Germany49 9131 85 47291christian.gulden@fau.de

Journal

Journal ID (nlm-ta): JMIR Med Inform

Journal ID (iso-abbrev): JMIR Med Inform

Journal ID (publisher-id): JMI

Title: JMIR Medical Informatics

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 2291-9694

Publication date Collection: January 2021

Publication date (Electronic): 12 January 2021

Volume: 9

Issue: 1

Electronic Location Identifier: e20470

Affiliations

[1 ] Chair of Medical Informatics Department of Medical Informatics, Biometrics and Epidemiology Friedrich-Alexander University Erlangen-Nürnberg Erlangen Germany

[2 ] Institute of Medical Informatics Justus-Liebig-University Gießen Gießen Germany

[3 ] Carl Gustav Carus Faculty of Medicine, Center for Medical Informatics Institute for Medical Informatics and Biometry Dresden University of Technology Dresden Germany

[4 ] Institute for Community Medicine Section Epidemiology of Health Care and Community Health University Medicine Greifswald Greifswald Germany

[5 ] Medical Informatics Group University Hospital Frankfurt Frankfurt Germany

[6 ] Medical Center for Information and Communication Technology University Hospital Erlangen Erlangen Germany

[7 ] Institute of Medical Biometry and Statistics Medical Faculty and Medical Center University of Freiburg Freiburg Germany

Author notes

Corresponding Author: Christian Gulden christian.gulden@ 123456fau.de

Author information

Christian Gulden https://orcid.org/0000-0003-1261-3691

Romina Blasini https://orcid.org/0000-0003-1049-6102

Azadeh Nassirian https://orcid.org/0000-0003-3987-1922

Alexandra Stein https://orcid.org/0000-0002-0600-9861

Fatma Betül Altun https://orcid.org/0000-0001-9718-1351

Melanie Kirchner https://orcid.org/0000-0001-9562-8877

Hans-Ulrich Prokosch https://orcid.org/0000-0001-6200-753X

Martin Boeker https://orcid.org/0000-0003-2972-2042

Article

Publisher ID: v9i1e20470

DOI: 10.2196/20470

PMC ID: 7837997

PubMed ID: 33433393

SO-VID: 6b250904-8ba1-4987-9685-4d624387007e

Copyright © ©Christian Gulden, Romina Blasini, Azadeh Nassirian, Alexandra Stein, Fatma Betül Altun, Melanie Kirchner, Hans-Ulrich Prokosch, Martin Boeker. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 12.01.2021.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Medical Informatics, is properly cited. The complete bibliographic information, a link to the original publication on http://medinform.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 19 May 2020

Date revision requested : 28 June 2020

Date revision received : 23 August 2020

Date accepted : 5 December 2020

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