The UMBRA Eight-Step Benefit-Risk Framework Framing the decision Step 1: Decision Context Identifying benefits and risks Step 2: Building the Value Tree Step 3: Refining the Value Tree Step 4: Relative Importance of Benefit and Risks Assessing benefits and risks Step 5: Evaluating the Options Step 6: Evaluating Uncertainty The slide shows the common elements of the UMBRA eight-step Benefit-Risk Framework that make up a systematic approach to benefit-risk assessment for medicines. At the 2012 CIRS annual Benefit-Risk Workshop 20-21 June (http://www.cirsci.org/system/files/private/CIRS_June_2012_Workshop_Synopsis.pdf) there was a consensus from those who are developing benefit risk methodologies for assessing medicines that there are four key stages namely Framing the decision; Identifying the benefits and risks; Assessing the benefits and risks and Providing interpretation and recommendation. Underpinning these was an overarching eight-step framework Decision context; Building the Value Tree; Value Tree refinement; Assessing relative importance; Evaluating options; Evaluating uncertainty; Concise presentation of results – visualisation and Final recommendation. All the methodologies currently being developed by regulators and companies have these steps whether they are explicitly or implicitly undertaken. The UMBRA overarching framework therefore, provides the basis for a common agreement on the principles for benefit-risk assessment of medicines. Step 7: Concise Presentation of Results (Visualisation) Step 8: Expert Judgement and Communication Interpretation and recommendations