title: Implemented data mining and signal management systems on spontaneous reporting systems' databases and their availability to the scientific community - a systematic review.
abstract: Adverse drug reactions' spontaneous reporting systems are an important element in worldwide pharmacovigilance, gathering potentially useful information for post-marketing drug safety surveillance. Data mining and signal management systems, providing the capability of reading and interpreting these systems' raw data (data that has not been subjected to processing or any other manipulation), improve its analysis process. In order for this analysis to be possible, both data mining and signal management systems and raw data should be available to researchers and the scientific community. The purpose of this work was to provide an overview of the spontaneous reporting systems databases reported in literature as having implemented a data mining and signal management system and the implementation itself, evidencing their availability to researchers. A systematic review was carried out, concluding that they are freely provided to researchers within institutions responsible for maintaining the spontaneous reporting systems, but not to most researchers within the scientific community.
authors.affiliation: University of Coimbra, Portugal. miguelvlima@gmail.com
authors.forename: Luis Miguel
authors.initials: LM
authors.lastname: de Almeida Vieira Lima
authors.forename: Nuno Goncalo Sales Craveiro
authors.initials: NG
authors.lastname: Nunes
authors.forename: Pedro Goncalo Pires
authors.initials: PG
authors.lastname: da Silva Dias
authors.forename: Francisco Jorge Batel
authors.initials: FJ
authors.lastname: Marques
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D003627:Data Interpretation, Statistical; D057225:Data Mining / Q000379:methods*; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing / Q000379:methods