You've found a safety signal - now what?

Sidney N Kahn

Signals detected by disproportionality of drug-event combinations are generally nothing more than statistical indicators of possible safety issues, and therefore require further analysis, validation, and evaluation of their clinical relevance. Signal strength per se does not necessarily correlate with medical significance. Strong signals may represent known, expected, and/or medically trivial adverse reactions, or confounding by treatment indication, common co-morbidities, or other common concomitant treatments, while weak signals may indicate rare medically important adverse drug reactions with a significant potential impact on benefit-risk balance.

This presentation will discuss follow up of identified signals, including:

· validity of the data used for signal generation
· assessment of clinical relevance of the signal
· organizational aspects of response to signals
· clinical/scientific response to signals (including additional information required for evaluation and assessment)
· possible regulatory impact