SHIELD:用于临床试验安全信号潜在发现的语义异质性集成嵌入方法 / SHIELD: Semantic Heterogeneity Integrated Embedding for Latent Discovery in Clinical Trial Safety Signals
1️⃣ 一句话总结
这篇论文提出了一种名为SHIELD的新方法,它通过结合统计分析和人工智能技术,自动将临床试验中分散的不良事件归类成有意义的信号群组,从而帮助研究人员更直观、高效地识别和理解药物的安全风险。
We present SHIELD, a novel methodology for automated and integrated safety signal detection in clinical trials. SHIELD combines disproportionality analysis with semantic clustering of adverse event (AE) terms applied to MedDRA term embeddings. For each AE, the pipeline computes an information-theoretic disproportionality measure (Information Component) with effect size derived via empirical Bayesian shrinkage. A utility matrix is constructed by weighting semantic term-term similarities by signal magnitude, followed by spectral embedding and clustering to identify groups of related AEs. Resulting clusters are annotated with syndrome-level summary labels using large language models, yielding a coherent, data-driven representation of treatment-associated safety profiles in the form of a network graph and hierarchical tree. We implement the SHIELD framework in the context of a single-arm incidence summary, to compare two treatment arms or for the detection of any treatment effect in a multi-arm trial. We illustrate its ability to recover known safety signals and generate interpretable, cluster-based summaries in a real clinical trial example. This work bridges statistical signal detection with modern natural language processing to enhance safety assessment and causal interpretation in clinical trials.
SHIELD:用于临床试验安全信号潜在发现的语义异质性集成嵌入方法 / SHIELD: Semantic Heterogeneity Integrated Embedding for Latent Discovery in Clinical Trial Safety Signals
这篇论文提出了一种名为SHIELD的新方法,它通过结合统计分析和人工智能技术,自动将临床试验中分散的不良事件归类成有意义的信号群组,从而帮助研究人员更直观、高效地识别和理解药物的安全风险。
源自 arXiv: 2602.19855