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arXiv · 2603.15936

CTG-DB: An Ontology-Based Transformation of ClinicalTrials.gov to Enable Cross-Trial Drug Safety Analyses

Jeffery L. Painter·François Haguinet·Andrew Bate
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Abstract

ClinicalTrials .gov (CT .gov) is the largest publicly accessible registry of clinical studies, yet its registry-oriented architecture and heterogeneous adverse event (AE) terminology limit systematic pharmacovigilance (PV) analytics. AEs are typically recorded as investigator-reported text rather than standardized identifiers, requiring manual reconciliation to identify coherent safety concepts. We present the ClinicalTrials .gov Transformation Database (CTG-DB), an open-source pipeline that ingests the complete CT .gov XML archive and produces a relational database aligned to standardized AE terminology using the Medical Dictionary for Regulatory Activities (MedDRA). CTG-DB preserves arm-level denominators, represents placebo and comparator arms, and normalizes AE terminology using deterministic exact and fuzzy matching to ensure transparent and reproducible mappings. This framework enables concept-level retrieval and cross-trial aggregation for scalable placebo-referenced safety analyses and integration of clinical trial evidence into downstream PV signal detection.

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Jeffery L. Painter, François Haguinet, Andrew Bate. 2026-03-18. CTG-DB: An Ontology-Based Transformation of ClinicalTrials.gov to Enable Cross-Trial Drug Safety Analyses. https://arxiv.org/abs/2603.15936

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