Ethical Considerations in the Design and Conduct of Clinical Trials of Artificial Intelligence.

Journal: JAMA network open
PMID: 39240560

Abstract

IMPORTANCE: Safe integration of artificial intelligence (AI) into clinical settings often requires randomized clinical trials (RCT) to compare AI efficacy with conventional care. Diabetic retinopathy (DR) screening is at the forefront of clinical AI applications, marked by the first US Food and Drug Administration (FDA) De Novo authorization for an autonomous AI for such use.

Authors

  • Alaa Youssef
    Department of Radiology, Stanford School of Medicine, Stanford, CA, USA.
  • Ariadne A Nichol
    Stanford School of Medicine, Stanford Center for Biomedical Ethics, Stanford, CA, United States.
  • Nicole Martinez-Martin
    Center for Biomedical Ethics, Stanford School of Medicine, Stanford, CA, USA.
  • David B Larson
    Department of Radiology, Warren Alpert Medical School, Brown University, 593 Eddy St, Providence, RI 02903 (I.P.); Department of Diagnostic Imaging, Rhode Island Hospital, Providence, RI (I.P.); Visiana, Hørsholm, Denmark (H.H.T.); Department of Radiology, Stanford University, Palo Alto, Calif (S.S.H., D.B.L.); and Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, Mass (J.K.C.).
  • Michael Abramoff
  • Risa M Wolf
    Department of Pediatric Endocrinology and Diabetes, Johns Hopkins University School of Medicine, Baltimore, MD.
  • Danton Char
    Division of Pediatric Cardiac Anesthesia, Department of Anesthesiology, Stanford University School of Medicine, San Francisco, California; Center for Biomedical Ethics, Stanford University School of Medicine, San Francisco, California.

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