Artificial intelligence agent in clinical trial operations: a fictional (for now) case study

AI agents are autonomous systems that catalyze drug development by processing vast data sets, modeling drug interactions, and optimizing synthesis protocols. Though not yet used in clinical trial operations, these agents could potentially manage data in electronic Case Report Forms (eCRFs), identifying anomalies, addressing basic issues, and creating reports—tasks that usually demand extensive human effort. Deploying AI agents in clinical trials could raise ethical concerns regarding autonomy, data privacy, bias, transparency, and accountability. Using a fictional use case, and building on ethical frameworks for biomedical research and on the Roche Data and AI Ethics Principles, the use of AI agents in clinical trials aims to balance efficiency with participant safety and rights, potentially hastening clinical research and the eventual approval of new treatments that could benefit patients and society while ensuring ethical integrity. This commentary explores ethical guardrails and risk mitigations.