Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions?
20-21 June 2012, Washington DC, USA
A survey undertaken by CIRS in 2011 identified the most significant barrier to implementing a formal benefit-risk framework within companies and agencies as the lack of a scientifically accepted model. This barrier exists despite the fact that there is generally good agreement as to the need and function of an appropriate framework as well as to the perceived advantages for implementing a framework as a tool for communication, structured discussion and enhancing transparency and accountability. A consensus is emerging that rather than a single benefit-risk methodology, a toolbox of methodologies derived from a common framework may be required that are flexible and adaptable for different situations. However, for this concept to be taken forward, agreement must be reached amongst the major stakeholders on a general scientifically acceptable benefit-risk framework.
Over the last five years, a number of initiatives have emerged from regulatory agencies such as the EMA, FDA and members of the Consortium on Benefit-Risk Assessment (COBRA) and from individual companies and industry consortia such as the Benefit-risk Action Team. These initiatives have developed qualitative and semi-quantitative methodologies, all of which have a number of common elements and which are being undertaken as pilot projects to test their application in real-world cases.
In 2012, as the development of benefit-risk methodologies moves forward through these initiatives, this workshop was designed to bring together the various stakeholders to discuss case studies in the context of the common elements of the various methodologies. The question is whether the stakeholders agree on a scientifically acceptable overarching framework for the benefit-risk assessment of medicines?
Workshop objectives
- Discuss the progress made since 2011 by different groups on defining an implementing a benefit-risk framework and specific methodologies within their organisations.
- Further the thinking as to what can be learnt from case studies and from each other about the different methodologies that can be used to make explicit benefit-risk decisions.
- Identify the common elements across methodologies and discuss how to achieve a consensus on a scientifically acceptable overarching framework for making benefit-risk decisions.