Benefit To Risk Analysis

Much of the debate about comparative benefit and risk is bedevielled by failures of logic and definition (for example clearly differentiating between "harm" and "risk") and the use of different criteria in different situations. It is very important that these issues are identified in any critical review of information. The UMC developments in this area involve:

* promotion of the principle that responsible safety information must involve an element of benefit-risk analysis

* the further development of definitions that are acceptable to the WHO collaborating national centres

* to develop much further on the CIOMS IV guidelines on the principles of benefit-risk comparison (Lindquist and Edwards, 1993)

* the development or promotion of methods that will enhance more rigorous benefit-risk analysis, for example

— comparing like with like (Edwards and Biriell, 1994)

— the use of best-case and worst-case analysis for uncertain safety information

— international analysis to highlight and to determine reasons for differences in reporting of ADRs (Mills and Edwards, 1999)

— analysis of ADR reports for comparator medical products when important safety signals are raised (Lindquist et al., 1996)

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