Embracing Generative Artificial Intelligence in Clinical Research and Beyond: Opportunities, Challenges, and Solutions.

Henry P Foote¹, Chuan Hong², Mohd Anwar³, Maria Borentain⁴, Kevin Bugin⁵, Nancy Dreyer⁶, Josh Fessel⁷, Nitender Goyal⁸, Morgan Hanger⁹, Adrian F Hernandez¹⁰, Christoph P Hornik¹⁰, Jennifer G Jackman¹⁰, Alistair C Lindsay¹¹, Michael E Matheny¹², Kerem Ozer¹³, Jan Seidel¹⁴, Norman Stockbridge⁵, Peter J Embi¹², Christopher J Lindsell¹⁵

¹Department of Pediatrics, Duke University, Durham, North Carolina, USA.

²Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA.

³National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, Maryland, USA.

⁴Bayer Corporation, Whippany, New Jersey, USA.

⁵United States Food and Drug Administration, Silver Spring, Maryland, USA.

⁶Dreyer Strategies, Newton, Massachusetts, USA.

⁷National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland, USA.

⁸Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.

⁹Clinical Trials Transformation Initiative Duke Clinical Research Institute, North Carolina, USA.

¹⁰Duke Clinical Research Institute, Durham, North Carolina, USA.

¹¹Janssen Pharmaceuticals, Horsham, Pennsylvania, USA.

¹²Vanderbilt University Medical Center, Nashville, Tennessee, USA.

¹³Novo Nordisk, Plainsboro, New Jersey, USA.

¹⁴Boehringer Ingelheim, Plainsboro, New Jersey, USA.

¹⁵Duke Clinical Research Institute, Durham, North Carolina, USA. Electronic address: chris.lindsell@duke.edu.

PubMed PMC DOI PDF

Abstract

To explore threats and opportunities and to chart a path for safely navigating the rapid changes that generative artificial intelligence (AI) will bring to clinical research, the Duke Clinical Research Institute convened a multidisciplinary think tank in January 2024. Leading experts from academia, industry, nonprofits, and government agencies highlighted the potential opportunities of generative…

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