ArticleTrials2016
A metadata schema for data objects in clinical research.
Article in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A systematic review of the blockchain application in healthcare research domain: toward a unified conceptual model.Medical & biological engineering & computing · 2025Pooled it
- Pooled it
- Topic-specific living databases of clinical trials: A scoping review of public databases.Clinical trials (London, England) · 2026Article
- TrialMatchAI: an end-to-end AI-powered clinical trial recommendation system to streamline patient-to-trial matching.Nature communications · 2026Article
- Publicly available continuously updated topic specific databases of randomised clinical trials: A scoping review.medRxiv : the preprint server for health sciences · 2024Article
- Schema Playground: a tool for authoring, extending, and using metadata schemas to improve FAIRness of biomedical data.BMC bioinformatics · 2023Article
- Harvesting metadata in clinical care: a crosswalk between FHIR, OMOP, CDISC and openEHR metadata.Scientific data · 2022Article
- Schema Playground: A tool for authoring, extending, and using metadata schemas to improve FAIRness of biomedical data.bioRxiv : the preprint server for biology · 2022Article
- Individual Patient-Level Data Sharing for Continuous Learning: A Strategy for Trial Data Sharing.NAM perspectives · 2019Review
- Sharing and reuse of individual participant data from clinical trials: principles and recommendations.BMJ open · 2017Article
- Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.Digital biomarkersArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme.
methodsThe relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored.
resultsA scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described.
conclusionsThe metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.