Artificial intelligence-enabled safety monitoring in Alzheimer's disease clinical trials.

Journal: The journal of prevention of Alzheimer's disease
PMID: 39800465

Abstract

BACKGROUND: Investigators conducting clinical trials have an ethical, scientific, and regulatory obligation to protect the safety of trial participants. Traditionally, safety monitoring includes manual review and coding of adverse event data by expert clinicians.

Authors

  • Gustavo A Jimenez-Maggiora
    Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, United States. Electronic address: gustavoj@usc.edu.
  • Michael C Donohue
    Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, United States.
  • Michael S Rafii
    Alzheimer's Disease Cooperative Study, Department of Neurosciences, University of California San Diego School of Medicine, La Jolla, CA, USA.
  • Rema Raman
    Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, United States.
  • Paul S Aisen
    Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, CA, United States.

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