Embracing Generative Artificial Intelligence in Clinical Research and Beyond
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,...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-03-01
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| Series: | JACC: Advances |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772963X25000109 |
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| author | Henry P. Foote, MD Chuan Hong, PhD Mohd Anwar, PhD Maria Borentain, MD Kevin Bugin, PhD Nancy Dreyer, PhD, MPH Josh Fessel, MD, PhD Nitender Goyal, MD Morgan Hanger, MPP Adrian F. Hernandez, MD Christoph P. Hornik, MD, PhD, MPH Jennifer G. Jackman, PhD, MBA Alistair C. Lindsay, MD, MPH, DPhil Michael E. Matheny, MD Kerem Ozer, MD Jan Seidel, PhD Norman Stockbridge, MD, PhD Peter J. Embi, MD Christopher J. Lindsell, PhD |
| author_facet | Henry P. Foote, MD Chuan Hong, PhD Mohd Anwar, PhD Maria Borentain, MD Kevin Bugin, PhD Nancy Dreyer, PhD, MPH Josh Fessel, MD, PhD Nitender Goyal, MD Morgan Hanger, MPP Adrian F. Hernandez, MD Christoph P. Hornik, MD, PhD, MPH Jennifer G. Jackman, PhD, MBA Alistair C. Lindsay, MD, MPH, DPhil Michael E. Matheny, MD Kerem Ozer, MD Jan Seidel, PhD Norman Stockbridge, MD, PhD Peter J. Embi, MD Christopher J. Lindsell, PhD |
| author_sort | Henry P. Foote, MD |
| collection | DOAJ |
| description | 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 AI in automation of documentation, strengthening of participant and community engagement, and improvement of trial accuracy and efficiency. Challenges include technical hurdles, ethical dilemmas, and regulatory uncertainties. Success is expected to require establishing rigorous data management and security protocols, fostering integrity and trust among stakeholders, and sharing information about the safety and effectiveness of AI applications. Meeting insights point towards a future where, through collaboration and transparency, generative AI will help to shorten the translational pipeline and increase the inclusivity and equitability of clinical research. |
| format | Article |
| id | doaj-art-08296cec39514b15a0ae96b41d265125 |
| institution | Kabale University |
| issn | 2772-963X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | JACC: Advances |
| spelling | doaj-art-08296cec39514b15a0ae96b41d2651252025-02-09T05:01:46ZengElsevierJACC: Advances2772-963X2025-03-0143101593Embracing Generative Artificial Intelligence in Clinical Research and BeyondHenry P. Foote, MD0Chuan Hong, PhD1Mohd Anwar, PhD2Maria Borentain, MD3Kevin Bugin, PhD4Nancy Dreyer, PhD, MPH5Josh Fessel, MD, PhD6Nitender Goyal, MD7Morgan Hanger, MPP8Adrian F. Hernandez, MD9Christoph P. Hornik, MD, PhD, MPH10Jennifer G. Jackman, PhD, MBA11Alistair C. Lindsay, MD, MPH, DPhil12Michael E. Matheny, MD13Kerem Ozer, MD14Jan Seidel, PhD15Norman Stockbridge, MD, PhD16Peter J. Embi, MD17Christopher J. Lindsell, PhD18Department of Pediatrics, Duke University, Durham, North Carolina, USADepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USANational Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, Maryland, USABayer Corporation, Whippany, New Jersey, USAUnited States Food and Drug Administration, Silver Spring, Maryland, USADreyer Strategies, Newton, Massachusetts, USANational Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland, USAAlnylam Pharmaceuticals, Cambridge, Massachusetts, USAClinical Trials Transformation Initiative Duke Clinical Research Institute, North Carolina, USADuke Clinical Research Institute, Durham, North Carolina, USADuke Clinical Research Institute, Durham, North Carolina, USADuke Clinical Research Institute, Durham, North Carolina, USAJanssen Pharmaceuticals, Horsham, Pennsylvania, USAVanderbilt University Medical Center, Nashville, Tennessee, USANovo Nordisk, Plainsboro, New Jersey, USABoehringer Ingelheim, Plainsboro, New Jersey, USAUnited States Food and Drug Administration, Silver Spring, Maryland, USAVanderbilt University Medical Center, Nashville, Tennessee, USADuke Clinical Research Institute, Durham, North Carolina, USA; Address for correspondence: Dr Christopher J. Lindsell, Duke Clinical Research Institute, 300 W Morgan Street, Durham, North Carolina 27701, USA.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 AI in automation of documentation, strengthening of participant and community engagement, and improvement of trial accuracy and efficiency. Challenges include technical hurdles, ethical dilemmas, and regulatory uncertainties. Success is expected to require establishing rigorous data management and security protocols, fostering integrity and trust among stakeholders, and sharing information about the safety and effectiveness of AI applications. Meeting insights point towards a future where, through collaboration and transparency, generative AI will help to shorten the translational pipeline and increase the inclusivity and equitability of clinical research.http://www.sciencedirect.com/science/article/pii/S2772963X25000109artificial intelligenceclinical researchgenerative AIparticipant engagementresearch ethics |
| spellingShingle | Henry P. Foote, MD Chuan Hong, PhD Mohd Anwar, PhD Maria Borentain, MD Kevin Bugin, PhD Nancy Dreyer, PhD, MPH Josh Fessel, MD, PhD Nitender Goyal, MD Morgan Hanger, MPP Adrian F. Hernandez, MD Christoph P. Hornik, MD, PhD, MPH Jennifer G. Jackman, PhD, MBA Alistair C. Lindsay, MD, MPH, DPhil Michael E. Matheny, MD Kerem Ozer, MD Jan Seidel, PhD Norman Stockbridge, MD, PhD Peter J. Embi, MD Christopher J. Lindsell, PhD Embracing Generative Artificial Intelligence in Clinical Research and Beyond JACC: Advances artificial intelligence clinical research generative AI participant engagement research ethics |
| title | Embracing Generative Artificial Intelligence in Clinical Research and Beyond |
| title_full | Embracing Generative Artificial Intelligence in Clinical Research and Beyond |
| title_fullStr | Embracing Generative Artificial Intelligence in Clinical Research and Beyond |
| title_full_unstemmed | Embracing Generative Artificial Intelligence in Clinical Research and Beyond |
| title_short | Embracing Generative Artificial Intelligence in Clinical Research and Beyond |
| title_sort | embracing generative artificial intelligence in clinical research and beyond |
| topic | artificial intelligence clinical research generative AI participant engagement research ethics |
| url | http://www.sciencedirect.com/science/article/pii/S2772963X25000109 |
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