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 |