Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source

• Published in: Briefings in bioinformatics Vol. 22; no. 6
• Main Authors: Noguchi, Yoshihiro, Tachi, Tomoya, Teramachi, Hitomi
• Format: Journal Article
• Language: English
• Published: England 05.11.2021
• Subjects: Adverse Drug Reaction Reporting Systems; Algorithms; Bayes Theorem; Data Mining; Databases, Factual; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drug-Related Side Effects and Adverse Reactions - epidemiology; Humans; Medical Informatics - methods; Models, Statistical; Odds Ratio; Reproducibility of Results; ROC Curve; time to onset algorithm; signal detection; disproportionality analysis; spontaneous reporting systems

Continuous evaluation of drug safety is needed following approval to determine adverse events (AEs) in patient populations with diverse backgrounds. Spontaneous reporting systems are an important source of information for the detection of AEs not identified in clinical trials and for safety assessme...