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Obstacles to the reuse of study metadata in ClinicalTrials.gov

Metadata that are structured using principled schemas and that use terms from ontologies are essential to making biomedical data findable and reusable for downstream analyses. The largest source of metadata that describes the experimental protocol, funding, and scientific leadership of clinical stud...

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Detalles Bibliográficos
Autores principales: Miron, Laura, Gonçalves, Rafael S., Musen, Mark A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749162/
https://www.ncbi.nlm.nih.gov/pubmed/33339830
http://dx.doi.org/10.1038/s41597-020-00780-z
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author Miron, Laura
Gonçalves, Rafael S.
Musen, Mark A.
author_facet Miron, Laura
Gonçalves, Rafael S.
Musen, Mark A.
author_sort Miron, Laura
collection PubMed
description Metadata that are structured using principled schemas and that use terms from ontologies are essential to making biomedical data findable and reusable for downstream analyses. The largest source of metadata that describes the experimental protocol, funding, and scientific leadership of clinical studies is ClinicalTrials.gov. We evaluated whether values in 302,091 trial records adhere to expected data types and use terms from biomedical ontologies, whether records contain fields required by government regulations, and whether structured elements could replace free-text elements. Contact information, outcome measures, and study design are frequently missing or underspecified. Important fields for search, such as condition and intervention, are not restricted to ontologies, and almost half of the conditions are not denoted by MeSH terms, as recommended. Eligibility criteria are stored as semi-structured free text. Enforcing the presence of all required elements, requiring values for certain fields to be drawn from ontologies, and creating a structured eligibility criteria element would improve the reusability of data from ClinicalTrials.gov in systematic reviews, metanalyses, and matching of eligible patients to trials.
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spelling pubmed-77491622020-12-21 Obstacles to the reuse of study metadata in ClinicalTrials.gov Miron, Laura Gonçalves, Rafael S. Musen, Mark A. Sci Data Analysis Metadata that are structured using principled schemas and that use terms from ontologies are essential to making biomedical data findable and reusable for downstream analyses. The largest source of metadata that describes the experimental protocol, funding, and scientific leadership of clinical studies is ClinicalTrials.gov. We evaluated whether values in 302,091 trial records adhere to expected data types and use terms from biomedical ontologies, whether records contain fields required by government regulations, and whether structured elements could replace free-text elements. Contact information, outcome measures, and study design are frequently missing or underspecified. Important fields for search, such as condition and intervention, are not restricted to ontologies, and almost half of the conditions are not denoted by MeSH terms, as recommended. Eligibility criteria are stored as semi-structured free text. Enforcing the presence of all required elements, requiring values for certain fields to be drawn from ontologies, and creating a structured eligibility criteria element would improve the reusability of data from ClinicalTrials.gov in systematic reviews, metanalyses, and matching of eligible patients to trials. Nature Publishing Group UK 2020-12-18 /pmc/articles/PMC7749162/ /pubmed/33339830 http://dx.doi.org/10.1038/s41597-020-00780-z Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Analysis
Miron, Laura
Gonçalves, Rafael S.
Musen, Mark A.
Obstacles to the reuse of study metadata in ClinicalTrials.gov
title Obstacles to the reuse of study metadata in ClinicalTrials.gov
title_full Obstacles to the reuse of study metadata in ClinicalTrials.gov
title_fullStr Obstacles to the reuse of study metadata in ClinicalTrials.gov
title_full_unstemmed Obstacles to the reuse of study metadata in ClinicalTrials.gov
title_short Obstacles to the reuse of study metadata in ClinicalTrials.gov
title_sort obstacles to the reuse of study metadata in clinicaltrials.gov
topic Analysis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749162/
https://www.ncbi.nlm.nih.gov/pubmed/33339830
http://dx.doi.org/10.1038/s41597-020-00780-z
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