Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

• Main Authors: Paola Maria Cutroneo (Author), Daniele Sartori (Author), Marco Tuccori (Author), Salvatore Crisafulli (Author), Vera Battini (Author), Carla Carnovale (Author), Concetta Rafaniello (Author), Annalisa Capuano (Author), Elisabetta Poluzzi (Author), Ugo Moretti (Author), Emanuel Raschi (Author)
• Format: Book
• Published: Frontiers Media S.A., 2024-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgmen...