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Randomized Controlled Trials in Medical AI: A Methodological Critique

Genin, Konstantin and Grote, Thomas (2021) Randomized Controlled Trials in Medical AI: A Methodological Critique. Philosophy of Medicine, 2 (1). pp. 1-15. ISSN 2692-3963

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Various publications claim that medical AI systems perform as well, or better, than clinical experts. However, there have been very few controlled trials and the quality of existing studies has been called into question. There is growing concern that existing studies overestimate the clinical benefits of AI systems. This has led to calls for more, and higher-quality, randomized controlled trials of medical AI systems. While this a welcome development, AI RCTs raise novel methodological challenges that have seen little discussion. We discuss some of the challenges arising in the context of AI RCTs and make some suggestions for how to meet them.

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Item Type: Published Article or Volume
Keywords: Artificial Intelligence Randomised Controlled Trials Clinical Methodology Machine Learning Medical Diagnosis
Subjects: Specific Sciences > Medicine > Clinical Trials
Depositing User: Professor Alex Broadbent
Date Deposited: 06 Sep 2022 14:10
Last Modified: 06 Sep 2022 14:10
Item ID: 21133
Journal or Publication Title: Philosophy of Medicine
Publisher: University Library System, University of Pittsburgh
Official URL:
DOI or Unique Handle: 10.5195/POM.2021.27
Subjects: Specific Sciences > Medicine > Clinical Trials
Date: 28 May 2021
Page Range: pp. 1-15
Volume: 2
Number: 1
ISSN: 2692-3963

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