Foote Henry P, Hong Chuan, Anwar Mohd, Borentain Maria, Bugin Kevin, Dreyer Nancy, Fessel Josh, Goyal Nitender, Hanger Morgan, Hernandez Adrian F, Hornik Christoph P, Jackman Jennifer G, Lindsay Alistair C, Matheny Michael E, Ozer Kerem, Seidel Jan, Stockbridge Norman, Embi Peter J, Lindsell Christopher J
Department of Pediatrics, Duke University, Durham, North Carolina, USA.
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA.
JACC Adv. 2025 Mar;4(3):101593. doi: 10.1016/j.jacadv.2025.101593. Epub 2025 Feb 8.
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.
为探索生成式人工智能（AI）给临床研究带来的快速变化所带来的威胁与机遇，并规划一条安全应对这些变化的路径，杜克临床研究所于2024年1月召集了一个多学科智囊团。来自学术界、行业、非营利组织和政府机构的顶尖专家强调了生成式AI在文档自动化、加强参与者和社区参与以及提高试验准确性和效率方面的潜在机遇。挑战包括技术障碍、伦理困境和监管不确定性。预计要取得成功，需要建立严格的数据管理和安全协议，促进利益相关者之间的诚信与信任，并分享有关AI应用安全性和有效性的信息。会议见解表明，未来通过合作与透明，生成式AI将有助于缩短转化流程，提高临床研究的包容性和公平性。
