Implemented Data Mining and Signal Management Systems on Spontaneous Reporting Systems’ Databases and their Availability to the Scientific Community - A Systematic Review

Luis      Miguel de Almeida Vieira Lima; Nuno      Goncalo Sales Craveiro Nunes; Pedro      Goncalo Pires da Silva Dias; Francisco      Jorge Batel Marques

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.

Keywords: Data mining, information system, pharmacovigilance, post-marketing safety surveillance, scientific community, signal detection software, spontaneous reporting system.

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