Visualising benefit risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making

16-17th June 2011, Washington DC, USA

In 2010 CIRS held its annual meeting on benefit-risk in Washington DC to discuss weightings and values within frameworks for the benefit-risk assessment of medicines. It was agreed at that meeting that one way of ensuring the development of the most effective framework is through undertaking scenarios with different stakeholders and products. This method allows the identification of ways in which agencies and companies will use the framework and establish practical methodologies to be used in the review of new medicines.

The 2010 workshop also identified a number of barriers to acceptance of a benefit-risk framework and possible solutions, which included continuing dialogue between agencies and companies and working through case study examples as a way of both evolving the thinking and gaining acceptance of the value of a process for articulating benefit-risk in a transparent manner.

In 2011, as the development of a benefit-risk framework moves forward through the US Food and Drug Administration, European Medicines Agency, Benefit-Risk Action Team (BRAT) of the Pharmaceutical Research and Manufacturers of America, and the consortium of four agencies being facilitated by CIRS, this workshop again brought these groups together with industry, many of whom are developing their own methodology with common objectives.

Workshop objectives

  • Discussing the progress made since 2010 by the different groups on defining an implementing a benefit-risk framework within their organisations.
  • Furthering the thinking regarding how to undertake weightings and valuing within the framework using worked examples/ scenarios and testing the difference between industry and agencies using practical examples.
  • Identifying how and what visualisation techniques can aid both the inputs and outputs of the process of describing benefit and risks and how this enables stakeholders to a better articulation, understanding and clarity of the benefit-risk decision.
Download