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OpenPVSignal Knowledge Graph: Pharmacovigilance Signal Reports in a Computationally Exploitable FAIR Representation
Achilleas Chytas1, George Gavriilides1, Anargyros Kapetanakis1
1Institute of Applied Biosciences, Centre for Research and Technology Hellas, Thessaloniki, Greece.
Introduction:
Pharmacovigilance signal report (PVSR) documents contain valuable condensed information published by drug monitoring organizations, typically in a free-text format. They provide initial insights into potential links between drugs and harmful effects. Still, their unstructured format prevents this valuable information from being integrated into data-processing pipelines (e.g., to support either the investigation of drug safety signals or decision-making in the clinical context).
Objective:
OpenPVSignal is a data model designed specifically to publish PVSRs via a computationally exploitable format, compliant with the FAIR (Findable, Accessible, Interoperable, Reusable) principles to promote ease of access and reusability of these valuable data.
Methods:
This paper outlines the procedure for converting pharmacovigilance signals published by the World Health Organization Uppsala Monitoring Centre (WHO-UMC) into the OpenPVSignal data model, resulting in a Knowledge Graph (KG). It details each step of the process, including the technical validation by KG engineers and the qualitative verification by medical and pharmacovigilance experts, leading to the finalized KG.
Results:
A total of 101 PVSRs from 2011 to 2019 were incorporated into the openly available KG.
Conclusion:
The presented KG could be useful in various data-processing pipelines, including systems that support drug safety activities.
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