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Randomised controlled trials in medical AI: ethical considerations
  1. Thomas Grote
  1. Ethics and Philosophy Lab, Cluster of Excellence "Machine Learning: New Perspectives for Science", University of Tübingen, Tübingen D-72076, Germany
  1. Correspondence to Thomas Grote, Ethics and Philosophy Lab, University of Tübingen, Tübingen D-72076, Germany; thomas.grote{at}


In recent years, there has been a surge of high-profile publications on applications of artificial intelligence (AI) systems for medical diagnosis and prognosis. While AI provides various opportunities for medical practice, there is an emerging consensus that the existing studies show considerable deficits and are unable to establish the clinical benefit of AI systems. Hence, the view that the clinical benefit of AI systems needs to be studied in clinical trials—particularly randomised controlled trials (RCTs)—is gaining ground. However, an issue that has been overlooked so far in the debate is that, compared with drug RCTs, AI RCTs require methodological adjustments, which entail ethical challenges. This paper sets out to develop a systematic account of the ethics of AI RCTs by focusing on the moral principles of clinical equipoise, informed consent and fairness. This way, the objective is to animate further debate on the (research) ethics of medical AI.

  • informed consent
  • research ethics
  • technology/risk assessment
  • clinical trials

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  • Contributors TG is the sole author of the paper.

  • Funding TG is supported by the Deutsche Forschungsgemeinschaft (BE5601/4-1; Cluster of Excellence ‘Machine Learning—New Perspectives for Science’, EXC 2064, project number 390727645).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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