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Table 1 New Structure of European Regulatory Assessment Reports for Benefit Risk Section

From: Current european regulatory perspectives on insulin analogues

step/task treatment effects level of uncertainties
review of benefits favourable effects:
beneficial effects, focussed on but not limited to clinical efficacy
uncertainty: impact of supportive data, subgroup differences, assumptions and expectations
review of risks unfavourable effects:
adverse drug reactions, drug-drug interactions, toxicity profile, potential for misuse, environmental impact
uncertainty: trial specifics, e.g. limited no. of patients, above average supervision in trials, non-clinical safety findings
value assignment compare and rank the favourable effects among each other
compare and rank the unfavourable effects among each other
discuss impact of uncertainties on ranking of favourable effects
discuss impact of uncertainties on ranking of unfavourable effects
Assessment of benefit-risk balance trade-off favours versus unfavours and discuss the benefit-risk balance critically discuss uncertainties in benefit-risk balance
discuss values according to perspectives of different stakeholders