Obstacles to the reuse of study metadata in ClinicalTrials.gov

Abstract 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 clin...

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Autores principales:	Laura Miron, Rafael S. Gonçalves, Mark A. Musen
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Science Q
Acceso en línea:	https://doaj.org/article/de4d450d9578451ba287fda864ffec3b
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spelling	oai:doaj.org-article:de4d450d9578451ba287fda864ffec3b2021-12-02T13:34:01ZObstacles to the reuse of study metadata in ClinicalTrials.gov10.1038/s41597-020-00780-z2052-4463https://doaj.org/article/de4d450d9578451ba287fda864ffec3b2020-12-01T00:00:00Zhttps://doi.org/10.1038/s41597-020-00780-zhttps://doaj.org/toc/2052-4463Abstract 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.Laura MironRafael S. GonçalvesMark A. MusenNature PortfolioarticleScienceQENScientific Data, Vol 7, Iss 1, Pp 1-14 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Science Q
spellingShingle	Science Q Laura Miron Rafael S. Gonçalves Mark A. Musen Obstacles to the reuse of study metadata in ClinicalTrials.gov
description	Abstract 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.
format	article
author	Laura Miron Rafael S. Gonçalves Mark A. Musen
author_facet	Laura Miron Rafael S. Gonçalves Mark A. Musen
author_sort	Laura Miron
title	Obstacles to the reuse of study metadata in ClinicalTrials.gov
title_short	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_sort	obstacles to the reuse of study metadata in clinicaltrials.gov
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/de4d450d9578451ba287fda864ffec3b
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Obstacles to the reuse of study metadata in ClinicalTrials.gov

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