1. The slide shows the seven key steps that make up a systematic approach to benefit-risk assessment for medicines.
Source: The CIRS Benefit-Risk Research Programme, which has the objective of achieving an internationally accepted approach for the systematic, routine and standardised documentation of decision making in the benefit-risk assessment of medicines. The next annual Workshop on the topic of Benefit-Risk is Visualising
benefit-risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, which will take place June 2011 in Washington, DC.
Recent CIRS publications on the topic of benefit-risk include:
Mussen F, Salek S and Walker SR, eds. Benefit-Risk Appraisal of Medicines: A Systematic Approach to Decision Making. John Wiley: Surrey, UK
Walker S, McAuslane N, Liberti L, Salek S. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. Clin Pharmacol Ther ;85:
Liberti L, McAuslane N, Walker S. Progress on the development of a benefit/risk framework for the evaluation of medicines. Regulatory Focus. March 2010.