Use of Smart contracts and AI agents in clinical trials

Author(s)	Bharathram Nagaiah
Country	United States
Abstract	The integration of smart contracts and AI agents in clinical trials fosters a new paradigm of transparent, efficient, and patient-centric research. Smart contracts—self-executing code on permissioned blockchains—automate protocol enforcement, consent capture, randomization, and remuneration. AI agents complement them by enabling intelligent participant matching, real-time safety monitoring, and adaptive analytics. In a simulated Phase II oncology trial and pilot implementations in rare-disease cohorts, this framework demonstrated up to 60% faster enrollment, 87% reduction in protocol deviations, near-instantaneous safety alerting, and near complete audit trails. This article details the system architecture, methodologies, results, discussion, and conclusions, with no speculation on future work.
Field	Engineering
Published In	Volume 16, Issue 4, October-December 2025
Published On	2025-10-21
DOI	https://doi.org/10.71097/IJSAT.v16.i4.8751
Short DOI	https://doi.org/g97jst

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International Journal on Science and Technology