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

2026-03-16 21:37:09
Jeffery L. Painter, Fran\c{c}ois Haguinet, Andrew Bate
arXiv_CL
           
Abstract

this http URL (this http URL) 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 this http URL Transformation Database (CTG-DB), an open-source pipeline that ingests the complete this http URL 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.

Abstract (translated)

URL

https://arxiv.org/abs/2603.15936

PDF

https://arxiv.org/pdf/2603.15936.pdf

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