Glissen Brown Jeremy R, Waljee Akbar K, Mori Yuichi, Sharma Prateek, Berzin Tyler M
Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA.
Division of Gastroenterology, University of Michigan Health System, University of Michigan, Ann Arbor, USA.
Dig Endosc. 2022 Jan;34(1):4-12. doi: 10.1111/den.13974. Epub 2021 Apr 19.
Gastroenterology has been an early leader in bridging the gap between artificial intelligence (AI) model development and clinical trial validation, and in recent years we have seen the publication of several randomized clinical trials examining the role of AI in gastroenterology. As AI applications for clinical medicine advance rapidly, there is a clear need for guidance surrounding AI-specific study design, evaluation, comparison, analysis and reporting of results. Several initiatives are in the publication or pre-publication phase including AI-specific amendments to minimum reporting guidelines for clinical trials, society task force initiatives aimed at priority use cases and research priorities, and minimum reporting guidelines that guide the reporting of clinical prediction models. In this paper, we examine applications of AI in clinical trials and discuss elements of newly published AI-specific extensions to the Consolidated Standards of Reporting Trials and Standard Protocol Items: Recommendations for Interventional Trials statements that guide clinical trial reporting and development. We then review AI applications at the pre-trial level in both endoscopy and other subfields of gastroenterology and explore areas where further guidance is needed to supplement the current guidance available at the pre-trial level.
胃肠病学在弥合人工智能（AI）模型开发与临床试验验证之间的差距方面一直处于领先地位，近年来，我们看到了几项关于AI在胃肠病学中作用的随机临床试验的发表。随着AI在临床医学中的应用迅速发展，显然需要围绕AI特定的研究设计、评估、比较、分析和结果报告提供指导。多项举措正处于发表或预发表阶段，包括针对临床试验最低报告指南的AI特定修订、针对优先使用案例和研究重点的学会特别工作组举措，以及指导临床预测模型报告的最低报告指南。在本文中，我们研究了AI在临床试验中的应用，并讨论了新发表的针对《报告试验的统一标准》和《标准协议项目：干预试验建议》的AI特定扩展内容，这些内容指导临床试验报告和开展。然后，我们回顾了AI在内镜检查和胃肠病学其他子领域的试验前水平应用，并探索了需要进一步指导以补充当前试验前水平可用指导的领域。
