The use of smart contracts and AI agents improves efficiency in clinical trials, suggesting faster enrollment and stronger audit trails.
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.
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Bharathram Nagaiah (2025) studied this question.
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