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Obstacles to the Reuse of Study Metadata in ClinicalTrials.gov

View ORCID ProfileLaura Miron, View ORCID ProfileRafael S. Gonçalves, View ORCID ProfileMark A. Musen
doi: https://doi.org/10.1101/850578
Laura Miron
Stanford Center for Biomedical Informatics Research, Stanford University School of Medicine, 1265 Welch Rd Stanford, CA 94305
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  • For correspondence: lmiron@stanford.edu
Rafael S. Gonçalves
Stanford Center for Biomedical Informatics Research, Stanford University School of Medicine, 1265 Welch Rd Stanford, CA 94305
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Mark A. Musen
Stanford Center for Biomedical Informatics Research, Stanford University School of Medicine, 1265 Welch Rd Stanford, CA 94305
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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.

Competing Interest Statement

The authors have declared no competing interest.

Footnotes

  • In response to editor comments from ScientificData, a figure, results, and discussion have been added about the differences in record completeness across sponsor-type (NIH, Industry, U.S. Fed, Other). Footnotes have been migrated to the main text, and statements about data and code availability have been added.

  • https://figshare.com/articles/dataset/Data_from_Obstacles_to_the_Reuse_of_Study_Metadata_in_ClinicalTrials_gov_/12743939

  • https://github.com/lauramiron/CTMetadataValidation

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license.
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Posted August 16, 2020.
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Obstacles to the Reuse of Study Metadata in ClinicalTrials.gov
Laura Miron, Rafael S. Gonçalves, Mark A. Musen
bioRxiv 850578; doi: https://doi.org/10.1101/850578
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Obstacles to the Reuse of Study Metadata in ClinicalTrials.gov
Laura Miron, Rafael S. Gonçalves, Mark A. Musen
bioRxiv 850578; doi: https://doi.org/10.1101/850578

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