Use of Smart contracts and AI agents in clinical trials

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.