Abstract
Pharmacovigilance regulations and guidelines state that literature databases should be searched at least monthly to detect safety signals from the published literature. In addition, periodic safety update reports (PSURs) should contain a summary and references from reports in the literature containing important safety findings. The volume of literature that needs to be reviewed is high, making manual review of the abstracts a resource-intensive process. Text Analytics for Surveillance (TAS) was developed as a software tool to improve the efficiency and consistency of the routine literature evaluation, tracking, and documentation process within a regulated pharmaceutical environment. Text Analytics for Surveillance uses natural language processing and includes a novel application of text analytics to assist with identifying the most relevant articles in the process of scheduled surveillance of published literature by enhancing categorized review, introducing consistency of approach, ensuring rigorous recording of activities, and aiding profile analysis. There are clear opportunities to reuse the TAS approach within other scientific and business areas where regular literature evaluation is important.
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Christensson, C., Gipson, G., Thomas, T. et al. Text Analytics for Surveillance (TAS): An Interactive Environment for Safety Literature Review. Ther Innov Regul Sci 46, 115–123 (2012). https://doi.org/10.1177/0092861511428890
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DOI: https://doi.org/10.1177/0092861511428890