ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1546897
This article is part of the Research TopicIndustrial Transformation through Blockchain: From Smart Manufacturing to Secure HealthcareView all 4 articles
BLOCKCHAIN-ENABLED QUALITY BY DESIGN SYSTEM FOR CLINICAL TRIALS
Provisionally accepted
Reza Vatankhah Barenji1*
Reza Ebrahimi Hariry2- 1School of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom
- 2University of Nottingham, Nottingham, England, United Kingdom
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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.
Keywords: clinical trials, Quality by design, Blockchain technology, Drug Development, PDCA
Received: 17 Dec 2024; Accepted: 11 Oct 2025.
Copyright: © 2025 Vatankhah Barenji and Hariry. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Reza Vatankhah Barenji, reza.vatankhah@hotmail.com
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