title: A knowledge management platform for documentation of case reports in pharmacovigilance.
abstract: Most countries have developed information systems to report drug adverse effects. However, as in other domains where systematic reviews are needed, there is little guidance on how systematic documentation of drug adverse effects should be performed. The objective of the VigiTermes project is to develop a platform to improve documentation of pharmacovigilance case reports for the pharmaceutical industry and regulatory authorities. In order to improve systematic reviews of adverse drug reactions, we developed a prototype that first reproduces and standardizes search strategies, then extracts information from the Medline abstracts which were retrieved and annotates them. The platform aims at providing transparent access and analysis tools to pharmacovigilance experts investigating relevance of safety signals related to drugs. The platform's architecture consists in the integration of two vendor tools ITM and Luxid and one academic web service for knowledge extraction from medical literature. Whereas a manual search performed by a pharmacovigilance expert retrieved 578 publications, the system proposed a list of 229 publications thus decreasing time required for review by 60%. Recall was 70% and additional developments are required in order to improve exhaustivity.
authors.affiliation: Mondeca, 75018 Paris, France. florence.amardeilh@mondeca.com
authors.forename: Florence
authors.initials: F
authors.lastname: Amardeilh
authors.forename: Cédric
authors.initials: C
authors.lastname: Bousquet
authors.forename: Sylvie
authors.initials: S
authors.lastname: Guillemin-Lanne
authors.forename: Mathilde
authors.initials: M
authors.lastname: Wiss-Thebault
authors.forename: Laetitia
authors.initials: L
authors.lastname: Guillot
authors.forename: Denis
authors.initials: D
authors.lastname: Delamarre
authors.forename: Agnès
authors.initials: A
authors.lastname: Lillo-Le Louet
authors.forename: Anita
authors.initials: A
authors.lastname: Burgun
mesh_terms: D019992:Databases as Topic; D004282:Documentation; D064420:Drug-Related Side Effects and Adverse Reactions; D004364:Pharmaceutical Preparations; D018511:Systems Integration
chemical_list: D004364:Pharmaceutical Preparations