Pharmacovigilance (PV) Signal Reports (SRs) are the consolidation of numerous Individual Case Safety Reports (ICSRs) by experts for the early detection of causal relationships between Drugs and Adverse Drug Reactions using statistical correlations. These reports currently exist in a format not useable by Information and Communications Technology (ICT) systems. OpenPVSignal model was an effort to bridge the gap between the SRs and ICTs by converting them to OWL/RDF format. This paper presents the resulting data from the conversion of 108 SRs using OpenPVSignal as the base data model.
The WHO-UMC data conversion to OWL/RDF has been an iterative process including multiple steps of data quality and validation while a set of researchers that consisted of 4 knowledge engineers and 2 domain experts (one pharmacologist and one physician) were involved in the process. Only a few signals were excluded because they did not focus on drug-ADR interactions, but rather incorrect drug usage or labelling. Figure 1 depicts a PVSR of the presented KG. The KG is openly available to download in Turtle syntax at a GitHub repository https://github.com/inab-certh/OpenPVSignal along with the methodology used for the data validation, while an openly published in a live RDF triple store exists to support exploration http://snf-893389.vm.okeanos.grnet.gr:7200/login. 15th International SWAT4HCLS Conference, February 26-29, 2024, Leiden, The Netherlands EMAIL: achytas@certh.gr (A. 1); nbassili@csd.auth.gr (A. 2); pnatsiavas@certh.gr (A.3) ORCID: 0000-0001-8486-011X (A. 1); 0000-0001-6035-1038 (A. 2); 0000-0002-4061-9815 (A. 3) ️© 2024 Copyright for this paper by its authors.
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OpenPVSignal is an open data source that consists of PVSRs in a FAIR (Findable-AccessibleInteroperable-Reusable) compliant format. Having these data available in a FAIR format could promote their systematic reuse and their integration within ICT systems and research pipelines. Additionally, the OWL semantics along with the rationale of symbolic AI can enable automatic reasoning upon them, further enhancing their potential by uncovering latent relationships among their Drug and Disease elements. Thus, the OpenPVSignal KG could play a prominent role in improving the early detection but also regarding the identification of underlying mechanisms of newly reported ADRs.