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Peer-Reviewed Publication
J Am Coll Cardiol2024;84(20):2051-2062.November 12, 2024Journal Article

Artificial Intelligence in Cardiovascular Clinical Trials.

Jonathan W Cunningham1, William T Abraham2, Ankeet S Bhatt3, Jessilyn Dunn4, G Michael Felker5, Sneha S Jain6, Christopher J Lindsell7, Matthew Mace8, Trejeeve Martyn9, Rashmee U Shah10, Geoffrey H Tison11, Tala Fakhouri12, Mitchell A Psotka13, Harlan Krumholz14, Mona Fiuzat15, Christopher M O'Connor16, Scott D Solomon17,
1Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
2The Ohio State University College of Medicine, Columbus, Ohio, USA.
3Division of Research, Kaiser Permanente Northern California, San Francisco, California, USA; Division of Cardiovascular Medicine, Stanford University, Stanford, California, USA.
4Department of Biostatistics and Bioinformatics and Department of Biomedical Engineering, Duke University, Durham, North Carolina, USA.
5Duke Clinical Research Institute, Durham, North Carolina, USA; Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
6Division of Cardiovascular Medicine, Stanford University, Stanford, California, USA.
7Department of Biostatistics and Bioinformatics and Department of Biomedical Engineering, Duke University, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA.
8Academy for HealthCare Science (AHCS), Lutterworth, United Kingdom; Acorai AB, Helsingborg, Sweden.
9Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
10University of Utah School of Medicine, Salt Lake City, Utah, USA.
11Division of Cardiology, University of California-San Francisco, San Francisco, California, USA.
12Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
13Inova Schar Heart and Vascular, Falls Church, Virginia, USA.
14Yale University School of Medicine, New Haven, Connecticut, USA.
15Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
16Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA; Inova Schar Heart and Vascular, Falls Church, Virginia, USA.
17Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: ssolomon@bwh.harvard.edu.
PubMed PMC DOI PDF

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 c…

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