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Prototype of running clinical trials in an untrustworthy environment using blockchain

Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use...

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Detalles Bibliográficos
Autores principales: Wong, Daniel R., Bhattacharya, Sanchita, Butte, Atul J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6384889/
https://www.ncbi.nlm.nih.gov/pubmed/30796226
http://dx.doi.org/10.1038/s41467-019-08874-y
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author Wong, Daniel R.
Bhattacharya, Sanchita
Butte, Atul J.
author_facet Wong, Daniel R.
Bhattacharya, Sanchita
Butte, Atul J.
author_sort Wong, Daniel R.
collection PubMed
description Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials.
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spelling pubmed-63848892019-02-25 Prototype of running clinical trials in an untrustworthy environment using blockchain Wong, Daniel R. Bhattacharya, Sanchita Butte, Atul J. Nat Commun Article Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and useful audit trail of trial data for regulators, and a flexible service for all members within the clinical trials network. We also improve the way adverse events are currently reported. In conclusion, we advocate that this service could offer an improvement in clinical trial data management, and could bolster trust in the clinical research process and the ease at which regulators can oversee trials. Nature Publishing Group UK 2019-02-22 /pmc/articles/PMC6384889/ /pubmed/30796226 http://dx.doi.org/10.1038/s41467-019-08874-y Text en © The Author(s) 2019 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 Article
Wong, Daniel R.
Bhattacharya, Sanchita
Butte, Atul J.
Prototype of running clinical trials in an untrustworthy environment using blockchain
title Prototype of running clinical trials in an untrustworthy environment using blockchain
title_full Prototype of running clinical trials in an untrustworthy environment using blockchain
title_fullStr Prototype of running clinical trials in an untrustworthy environment using blockchain
title_full_unstemmed Prototype of running clinical trials in an untrustworthy environment using blockchain
title_short Prototype of running clinical trials in an untrustworthy environment using blockchain
title_sort prototype of running clinical trials in an untrustworthy environment using blockchain
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6384889/
https://www.ncbi.nlm.nih.gov/pubmed/30796226
http://dx.doi.org/10.1038/s41467-019-08874-y
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