BLOCKCHAIN-ENABLED QUALITY BY DESIGN SYSTEM FOR CLINICAL TRIALS

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Ranked #288 of 309 articles by views in Frontiers in pharmacology

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Abstract
In this paper, blockchain technology is utilized as a distributed data management system and integrated with the Quality by Design (QbD) systematic approach to enhance the quality of clinical trials. This integration aims to boost data integrity within QbD activities and promote participant safety. First, a blockchain-enabled QbD architecture is proposed, and the interactions among its enablers and peers are described. Then, a prototype of the proposed architecture is developed, and data from a pilot trial are used to validate its applicability. The results demonstrate that the proposed architecture is efficient and feasible for adoption in clinical trials. With the successful development of this architecture, it shows promise in enabling effective data integration and knowledge management to improve participant safety.
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imported_1760285520_68ebd350a8030 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Hariry, Reza Ebrahimi
Journal Frontiers in pharmacology
Year Year not found
DOI
10.3389/fmed.2025.1546897
URL
https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1546897/full
Keywords Keywords not found

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