用AI自动匹配患者与临床试验,提升精准医疗效率
TrialMatchAI: An End-to-End AI-powered Clinical Trial Recommendation System to Streamline Patient-to-Trial Matching
- 基于大模型和检索增强生成,融合结构化与非结构化病历数据
- 92%肿瘤患者在前20条推荐中找到相关试验,判别准确率超90%
- 支持本地部署、可解释决策,适合医院和研究机构快速落地
患者招募仍是临床试验的主要瓶颈,亟需可扩展的自动化解决方案。我们提出TrialMatchAI,一个端到端的AI推荐系统,通过处理异构临床数据(包括结构化记录和医生笔记)实现患者与试验的自动匹配。系统基于微调的开源大语言模型,在检索增强生成框架下运行,确保透明性和可复现性,并具备轻量级部署特性,适合临床环境。系统对生物医学实体进行标准化,采用混合搜索策略(词法与语义相似性结合)检索相关试验,重新排序结果,并使用医学链式思维推理进行逐条入组标准评估,输出可追溯的决策依据。真实世界验证显示,92%的肿瘤患者在前20个推荐中至少匹配到一个相关试验。在合成与真实临床数据集上的评估均达到业界领先水平,专家评估确认其入组标准分类准确率超过90%,尤其在生物标志物驱动的匹配中表现突出。系统设计具备模块化与隐私保护能力,支持Phenopackets标准数据,可安全本地部署,并允许未来无缝替换大模型组件。通过提升效率、可解释性及轻量化开源部署,TrialMatchAI为精准医疗中的AI驱动临床试验匹配提供可扩展解决方案。
原文摘要 · Abstract (English)
Patient recruitment remains a major bottleneck in clinical trials, calling for scalable and automated solutions. We present TrialMatchAI, an AI-powered recommendation system that automates patient-to-trial matching by processing heterogeneous clinical data, including structured records and unstructured physician notes. Built on fine-tuned, open-source large language models (LLMs) within a retrieval-augmented generation framework, TrialMatchAI ensures transparency and reproducibility and maintains a lightweight deployment footprint suitable for clinical environments. The system normalizes biomedical entities, retrieves relevant trials using a hybrid search strategy combining lexical and semantic similarity, re-ranks results, and performs criterion-level eligibility assessments using medical Chain-of-Thought reasoning. This pipeline delivers explainable outputs with traceable decision rationales. In real-world validation, 92 percent of oncology patients had at least one relevant trial retrieved within the top 20 recommendations. Evaluation across synthetic and real clinical datasets confirmed state-of-the-art performance, with expert assessment validating over 90 percent accuracy in criterion-level eligibility classification, particularly excelling in biomarker-driven matches. Designed for modularity and privacy, TrialMatchAI supports Phenopackets-standardized data, enables secure local deployment, and allows seamless replacement of LLM components as more advanced models emerge. By enhancing efficiency and interpretability and offering lightweight, open-source deployment, TrialMatchAI provides a scalable solution for AI-driven clinical trial matching in precision medicine.
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