Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Blockchain-Enabled Quality Improvement Digital Twin for Clinical Trials

Version 1 : Received: 23 May 2023 / Approved: 24 May 2023 / Online: 24 May 2023 (04:46:13 CEST)

How to cite: Vatankhah Barenji, R.; Ebrahimi Hariry, R. Blockchain-Enabled Quality Improvement Digital Twin for Clinical Trials. Preprints 2023, 2023051693. https://doi.org/10.20944/preprints202305.1693.v1 Vatankhah Barenji, R.; Ebrahimi Hariry, R. Blockchain-Enabled Quality Improvement Digital Twin for Clinical Trials. Preprints 2023, 2023051693. https://doi.org/10.20944/preprints202305.1693.v1

Abstract

Clinical trials are research studies performed on people that are aimed at evaluating a medical, surgical, or behavioural intervention. It is a primary way that researchers find out if a new treatment, like a new drug or diet, or medical device is safe and effective in people. In this paper blockchain technology is embedded in a digital twin aiming to improve the quality of clinical trials through the boost of data integrity among the quality-related activities, and to promote participants' safety. First, a blockchain-embedded quality-enabled digital twin is proposed and the interactions among the enablers and peers are highlighted. Then, a prototype of the proposed system is developed, and the data of a pilot trial is used to justify the applicability of the system. The results showed that the proposed system is efficient, and hence it is feasible to adopt into a clinical trial. With the successful development of the proposed system, it is promising to provide effective data integration and knowledge management for improving participant safety.

Keywords

Digital twin; Clinical trials; Quality by Design; Blockchain technology; Drug development

Subject

Computer Science and Mathematics, Artificial Intelligence and Machine Learning

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