Background

The Unified Methodologies for Benefit-Risk Assessment (UMBRA) initiative was established by CIRS in 2012 to provide a platform for the coordinated development of benefit-risk assessment methodologies that can be used internationally during the drug development and regulatory review and post-approval periods.   The goals of this programme are to increase the transparency, predictability and consistency with which benefit-risk assessments are conducted.

Research into the assessment of the benefits and harms of medicines is a dynamic, globally active arena, and the UMBRA Initiative’s activities reflect these endeavours. The UMBRA Initiative fosters activities in the benefit-risk area in part through its Benefit-Risk Taskforce.  The Taskforce has been designed to facilitate the exchange of information, reports and published papers among relevant stakeholders to ensure effective knowledge sharing and the exchange of learnings from these various parties. 

 CIRS uses the following definitions to distinguish the relationship between the Framework and methodologies:

Framework: A set of common principles that support tailored approaches to benefit-risk decision making. A framework approach recognizes that a structured and systematic process plays an essential and fundamental role in assisting and improving human decision making.  The principles of a common framework set the stage for the methodologies and tools that are relevant the analysis at hand (ie pre-approval, post-approval etc). CIRS is in the process of finalising a globally acceptable, standardized Framework, which will represent the second-generation evolution of the current Framework model.

Methodologies: The tools (and guidelines for their use) to facilitate the articulation, communication and visualisation of benefits and risks.  Methodologies are the platform through which issues relating to benefit and risk can be shared between stakeholders, such as sponsors, regulators, health care professionals and patients, helping to identify similarities and differences in the approaches to the assessment. These methodologies form part of a dynamic ‘toolbox’ of different approaches to the assessment of benefits and harms and should encompass the views of all stakeholders, thereby leading to greater transparency of development and regulatory decisions.

 The relationship between the common Framework and the toolbox of unique methodologies is represented as follows: