An Autonomous Agent for Real-time Monitoring and Management of Clinical Trial Protocol Adherence

4/16/2025 • JMIR Medical Informatics • License: CC BY

Zhang, Y.

Abstract

To ensure the integrity of clinical trials, we developed an AI agent that continuously monitors trial data within the EHR. The agent autonomously cross-references patient activities against the trial protocol and flags potential deviations, such as missed appointments or incorrect lab tests, in real-time. In a simulated deployment, the agent identified 98% of protocol deviations within one hour of occurrence, compared to weeks in traditional manual auditing.

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Clinical implications

An AI agent was built to act as a watchdog for clinical trials. It constantly checks patient data to make sure the trial's rules are being followed correctly. This agent can spot and flag mistakes almost instantly, whereas human auditors might take weeks to find the same issues, thus improving trial quality and safety.

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