POCUS-REPORT: The REporting a Time-to-onset Anaysis using Individual Case Safety reports in PharmacoVigilance

Observational studies

As part of the utilization of the Individual case safety reports (ICSR) database, Time-to-Onset (TTO) analyses based on drug-related adverse event reports in the database is actively being performed in conjunction. Several reporting guidelines have been developed for observational studies, including STROBE, RECORD-PE and READUS-PV. However, these guidelines are outside the scope of reporting TTO analyses. Therefore, TTO analyses are often poorly reported and interpreted.

Registered: 18 June 2025

Last updated:

Contact: Yoshihiro Noguchi, Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University Email: [email protected]