FRESH: Information-Geometric Calibration of Patient-Level Models to Aggregate Evidence
FRESH:信息几何校准患者级模型以聚合证据
Franklin Fuller, Daniele Bertolini, Samantha Liang, Jason Christopher, Aaron M. Smith
AI总结 FRESH通过信息几何方法将群体层面结果与患者层面数据结合,提升临床决策模型的效率与准确性。
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本文介绍FRESH(近期证据与患者历史融合),一种将群体层面总结结果——已发表的临床试验、注册摘要、先前自然史研究和同行评审的间接比较——纳入基于患者层面数据训练的预测模型中的方法。该方法提供了一种系统地将患者层面和汇总层面数据类型结合到统一的、数据高效的模型中的方法,用于临床决策。FRESH假设可以访问一个基于患者层面数据源(例如临床试验或真实世界数据)训练的生成模型。该方法通过重新校准的模型产生患者层面的预测,该模型匹配目标人群指定的汇总统计量。这可以理解为对汇总源的患者层面重演——其关键特性是重新校准是对原始联合分布在特定信息几何意义上的最小扰动。生成的样本可以直接分析或结合到后训练过程中以更新原始生成模型。这种方法使在需要严格纳入患者层面数据与汇总信息的多个应用中变得可行,包括(i)将单臂试验结果与最近的标准化护理进行上下文化,(ii)用于临床试验设计和技术成功概率估计的临床试验模拟,以及(iii)对上市药物的比较有效性分析。
This note introduces FRESH (Fusion of Recent Evidence and Subject Histories), a method for incorporating population-level summary results -- published clinical trials, registry summaries, prior natural-history studies, and peer-reviewed indirect comparisons -- into predictive models trained on patient-level data. This method provides a principled means of combining both patient-level and aggregate-level data types into a unified data-efficient model for clinical decision making. FRESH assumes access to a generative model trained on patient-level data sources (e.g. clinical trial or real-world data). The method produces patient-level predictions from a re-calibrated model that matches a set of specified aggregate statistics for a target population. This can be understood as a patient-level recapitulation of the aggregate source -- with the key property that the recalibration is a minimal perturbation of the original joint distribution in a specific information-geometric sense. The resulting samples can be analyzed directly or combined into a post-training procedure to update the original generative model. This approach enables several applications where rigorously incorporating patient-level data with summary information is valuable, including (i) contextualizing single-arm trial results with respect to recent standard-of-care, (ii) clinical-trial simulations for design and probability-of-technical-success estimation, and (iii) comparative-effectiveness analyses of on-market therapies.