The overarching elements of a framework for Benefit-Risk assessment have been well articulated over the last five years resulting in there being commonality in the steps taken by both agencies and companies to assess a medicine’s benefit-risk profile. As companies and agencies embedded this framework into their decision-making process as a key tool to inform the discussion around the benefit risk assessment, a number of key questions arise:
• How can we ensure that the Framework is actively used as part of the decision process?
• What is the process for its incorporation within current decision-making procedures?
• How can the Framework help improve the quality of the decision to progress or submit a new medicine?
Over the last 3 years, in addition to the work to develop a systematic structured approach to benefit risk, CIRS has undertaken a project to identify the important issues that influence quality decision-making from the perspective of the individual and organisations. As a result of this background research, a draft framework for good decision making in the development and review of medicines has been developed.
As the benefit-risk framework is now becoming the cornerstone of building quality into the critical decisions being made within companies and agencies, CIRS is interested in understanding and identifying how the benefit-risk decision framework is being built into the broader decision-making process.