Artificial Intelligence in Cardiovascular Clinical Trials.

Journal: Journal of the American College of Cardiology
PMID: 39505413

Abstract

Randomized clinical trials are the gold standard for establishing the efficacy and safety of cardiovascular therapies. However, current pivotal trials are expensive, lengthy, and insufficiently diverse. Emerging artificial intelligence (AI) technologies can potentially automate and streamline clinical trial operations. This review describes opportunities to integrate AI throughout a trial's life cycle, including designing the trial, identifying eligible patients, obtaining informed consent, ascertaining physiological and clinical event outcomes, interpreting imaging, and analyzing or disseminating the results. Nevertheless, AI poses risks, including generating inaccurate results, amplifying biases against underrepresented groups, and violating patient privacy. Medical journals and regulators are developing new frameworks to evaluate AI research tools and the data they generate. Given the high-stakes role of randomized trials in medical decision making, AI must be integrated carefully and transparently to protect the validity of trial results.

Authors

  • Jonathan W Cunningham
    Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: jcunningham3@bwh.harvard.edu.
  • William T Abraham
    The Ohio State University College of Medicine, Columbus, Ohio, USA.
  • Ankeet S Bhatt
    Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, CA, USA.
  • Jessilyn Dunn
    Biomedical Engineering Department, Duke University, Durham, NC 27708, USA.
  • G Michael Felker
    Duke Clinical Research Institute, Duke University, Durham, NC.
  • Sneha S Jain
    Division of Cardiology, Stanford University School of Medicine, Palo Alto, California, USA.
  • Christopher J Lindsell
    Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH.
  • Matthew Mace
    Academy for HealthCare Science (AHCS), Lutterworth, United Kingdom; Acorai AB, Helsingborg, Sweden.
  • Trejeeve Martyn
    Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
  • Rashmee U Shah
    Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City.
  • Geoffrey H Tison
    Department of Medicine (G.H.T., M.H.L., E.F., M.A.A., C.J., K.E.F., R.C.D.).
  • Tala Fakhouri
    Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Mitchell A Psotka
    Inova Schar Heart and Vascular, Falls Church, Virginia, USA.
  • Harlan Krumholz
    Yale University School of Medicine, New Haven, Connecticut, USA.
  • Mona Fiuzat
    Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
  • Christopher M O'Connor
    Inova Schar Heart and Vascular, Falls Church, Virginia, USA; Duke Clinical Research Institute, Durham, North Carolina, USA.
  • Scott D Solomon
    Brigham and Women's Hospital, Boston, MA, USA.

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