Life sciences · Türkiye
Pharmacovigilance and real-world evidence
Identify expertise in safety monitoring, registries or observational evidence. An adverse event report can raise a signal; it cannot on its own establish causality.
Scientific background
A safety signal prompts evaluation. Without a reliable denominator, spontaneous reports alone cannot tell a company how often a reaction occurs.
TÜFAM receives reports of suspected adverse reactions in Türkiye. A single report can prompt investigation but cannot by itself establish causation or frequency. A company planning a safety project may seek a contact with the appropriate expertise. Individual case reports belong in the official reporting channels.
Wang and colleagues compared 32 selected randomised trials with emulations using US claims data. The studies met the authors’ estimate-agreement criterion in 66% of comparisons. Results depended in part on how closely the available data could represent the original design. For a Turkish registry project, discuss population coverage, outcome measurement and potential confounding before choosing a data partner.
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