arXiv:2512.07694cs.CL2025-12被引 2

用AI自动生成药物安全监测的标准化术语查询,提升信号检测效率。

Automated Generation of Custom MedDRA Queries Using SafeTerm Medical Map

  • 通过向量空间匹配输入术语与医学标准术语,用相似度排序。
  • 在0.70-0.75阈值下,召回率约50%,精确率达33%。
  • 适合药企和监管机构快速构建合规的不良反应查询集。

在新药上市前的安全评估中,将相关不良事件术语归类为标准化的MedDRA查询或FDA新药办公室自定义医学查询(OCMQs)对信号检测至关重要。我们提出一种新型定量人工智能系统SafeTerm,可理解并处理医学术语,基于多准则统计方法对给定查询自动检索相关MedDRA首选术语(PTs),并按相关性得分排序。该系统将医疗查询术语与MedDRA PTs嵌入多维向量空间,结合余弦相似度与极值聚类生成排序列表。在包含104个查询的FDA OCMQ v3.0数据集上进行验证,仅限有效MedDRA PTs。在不同相似度阈值下计算精确率、召回率与F1值:中等阈值下召回率超过95%;更高阈值可提升精确率至86%。最优阈值(约0.70–0.75)下,召回率约50%,精确率约33%。窄术语子集表现相近,但需略高相似度阈值。SafeTerm系统为自动化生成MedDRA查询提供了可行补充方案。建议初始使用约0.60阈值,后续提高以精炼术语选择。

原文摘要 · Abstract (English)

In pre-market drug safety review, grouping related adverse event terms into standardised MedDRA queries or the FDA Office of New Drugs Custom Medical Queries (OCMQs) is critical for signal detection. We present a novel quantitative artificial intelligence system that understands and processes medical terminology and automatically retrieves relevant MedDRA Preferred Terms (PTs) for a given input query, ranking them by a relevance score using multi-criteria statistical methods. The system (SafeTerm) embeds medical query terms and MedDRA PTs in a multidimensional vector space, then applies cosine similarity and extreme-value clustering to generate a ranked list of PTs. Validation was conducted against the FDA OCMQ v3.0 (104 queries), restricted to valid MedDRA PTs. Precision, recall and F1 were computed across similarity-thresholds. High recall (>95%) is achieved at moderate thresholds. Higher thresholds improve precision (up to 86%). The optimal threshold (~0.70 - 0.75) yielded recall ~50% and precision ~33%. Narrow-term PT subsets performed similarly but required slightly higher similarity thresholds. The SafeTerm AI-driven system provides a viable supplementary method for automated MedDRA query generation. A similarity threshold of ~0.60 is recommended initially, with increased thresholds for refined term selection.

药物安全AI辅助医学术语信息检索

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