Roche Template

Naranjo algorithm at Roche
• Survey of 55’000 cases scored over a 2 year period 2005-2007:
‟ Study cases: 43 causality `upgraded’ because score 5
‟ Spontaneous cases: 12 causality `upgraded’ because score 5
• We now assume `related’ for all spontaneously reported events unless reporter explicitly states `not related’
• Perceived limitations
‟ Little added value
‟ Time consuming (strictly, requires a review of previous cases)
‟ Information needed to assess probability of a causal relationship depends on the drug-event pair in question (i.e.
not the same for all DEPs)