Leveraging Post-marketing Drug Safety Research through Semantic Technologies: The PharmacoVigilance Signal Detectors Ontology

Accurate and timely identification of post-marketing drug safety risks (the so-called “signals” in pharmacovigilance) is an important public health issue. While various computational methods have been proposed to analyze the diverse data sources employed for signal detection, still the challenge of effective drug monitoring and surveillance remains. On the other hand, there is an emerging belief that the synthesis of all possible information sources is necessary to achieve further advancements. Aiming to facilitate integrated signal detection by concurrently exploring various data sources via respective analysis methods in a systematic way, we propose the PharmacoVigilance Signal Detectors Ontology (PV-SDO). PV-SDO constitutes the backbone of a semantically-enriched platform for this integration and aims to: (a) semantically harmonize heterogeneous data sources and analysis methods in the field, (b) facilitate their joint exploitation through mappings between reference terminologies that the data sources rely on, and (c) provide an exploitable knowledge base of signal analysis methods, experiments and their outcomes including provenance information. PV-SDO has been populated with a significant number of individuals using data from open-source signal detection method implementations, and assessed via data-driven and logicbased techniques, while an evaluation with experts is currently being conducted with well-promising results.