用AI自动提取临床试验协议信息,提升准确率与效率。
AI-assisted Protocol Information Extraction For Improved Accuracy and Efficiency in Clinical Trial Workflows
- 基于RAG的AI系统从协议中抽取信息,准确率89%
- 相比普通大模型,信息提取准确率提升26.4个百分点
- 实测可让研究人员工作提速40%,更省力易用
临床试验协议日益复杂,知识管理难度加大,给研究团队带来沉重负担。将协议内容结构化为标准格式,有助于提升效率、保障文档质量并强化合规性。本文评估了一种基于生成式大语言模型与检索增强生成(RAG)技术的AI系统,在自动化提取临床试验协议信息方面的表现。通过与公开可用的独立大模型对比,我们发现该专用于临床试验的RAG流程在专家标注参考下,提取准确率达89.0%,显著高于微调提示后的独立大模型(62.6%)。在模拟临床研究协调员(CRC)工作流程中,使用AI辅助的任务完成速度提升40%,用户评价其认知负荷更低,且强烈偏好该方式。尽管仍需专家监督,结果表明AI辅助提取可实现协议信息的规模化智能处理,推动类似方法在真实临床工作流中的集成,进一步验证其在研究启动、激活后监测等环节的可行性与价值。
原文摘要 · Abstract (English)
Increasing clinical trial protocol complexity, amendments, and challenges around knowledge management create significant burden for trial teams. Structuring protocol content into standard formats has the potential to improve efficiency, support documentation quality, and strengthen compliance. We evaluate an Artificial Intelligence (AI) system using generative LLMs with Retrieval-Augmented Generation (RAG) for automated clinical trial protocol information extraction. We compare the extraction accuracy of our clinical-trial-specific RAG process against that of publicly available (standalone) LLMs. We also assess the operational impact of AI-assistance on simulated extraction Clinical Research Coordinator (CRC) workflows. Our RAG process shows higher extraction accuracy (89.0%) than standalone LLMs with fine-tuned prompts (62.6%) against expert-supported reference annotations. In simulated extraction workflows, AI-assisted tasks are completed 40% faster, are rated as less cognitively demanding and are strongly preferred by users. While expert oversight remains essential, this suggests that AI-assisted extraction can enable protocol intelligence at scale, motivating the integration of similar methodologies into real-world clinical workflows to further validate its impact on feasibility, study start-up, and post-activation monitoring.
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