Enhancing Postmarketing Surveillance of Medical Products With Large Language Models.

Journal: JAMA network open
PMID: 39150707

Abstract

IMPORTANCE: The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA advisory committee meetings, and other regulatory decisions. However, observational data are frequently deemed insufficient for reliable evaluation of safety concerns owing to limitations in underlying data or methodology. Advances in large language models (LLMs) provide new opportunities to address some of these limitations. However, careful consideration is necessary for how and where LLMs can be effectively deployed for these purposes.

Authors

  • Michael E Matheny
    Vanderbilt University School of Medicine, Nashville, TN.
  • Jie Yang
    Key Laboratory of Development and Maternal and Child Diseases of Sichuan Province, Department of Pediatrics, Sichuan University, Chengdu, China.
  • Joshua C Smith
    Vanderbilt University Medical Center, Nashville, TN.
  • Colin G Walsh
    Vanderbilt University Medical Center, Vanderbilt University, Nashville, TN, United States.
  • Mohammed A Al-Garadi
    Department of Biomedical Informatics, Emory University, Atlanta, GA, USA.
  • Sharon E Davis
    Vanderbilt University School of Medicine, Nashville, TN.
  • Keith A Marsolo
    Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
  • Daniel Fabbri
    Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.
  • Ruth R Reeves
    Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee.
  • Kevin B Johnson
    Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, United States.
  • Gerald J Dal Pan
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Robert Ball
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.
  • Rishi J Desai
    Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

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