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Decision Making:

UMBRA Initiative

Background

Since January 2012, CIRS has consolidated its various activities in the field of benefit-risk assessment under the umbrella of the “UMBRA Initiative.” UMBRA – Unified Methodologies for Benefit-Risk Assessment – provides a single platform for the development, assessment, implementation and ongoing refinement of an internationally acceptable, structured, systematic, standardised approach to the benefit-risk assessment of medicines.

Methodologies

The tools and guidelines for their use that enable a structured approach to decision making and facilitate the articulation, communication and visualisation of benefits and risks. These methodologies encompass the views of all stakeholders, thereby leading to greater transparency of development and regulatory decisions, which help identify similarities and differences in the overall benefit-risk assessment.

iSABRE

The UMBRA framework has been evaluated and found fit for purpose by regulatory agencies in Canada, Australia, Switzerland and Singapore. The Summary portion of this system, which consists of the Benefit-Risk Template and User Manual, has recently been evaluated by in the CIRS Summary Approach to Benefit-Risk Evaluation (SABRE) feasibility and pilot studies by regulatory agencies in China, Indonesia, Malaysia, Philippines and Chinese Taipei. Participants rated the Benefit-Risk Summary Template as good to excellent in navigation, clarity of instructions and applicability and comprehensiveness of guidance. They additionally indicated that the template has the advantages of the systems currently in use in their organisation, contributes to achieving consistency of decisions between regulatory agencies and promotes effective communication to stakeholders. For regulatory agencies in maturing markets, the use of the CIRS Benefit-Risk Summary Template may afford an understanding of the reference agency benefit-risk evaluation and the ways in which it maps to the overarching framework, while providing a structured approach for reaching a local decision regarding the benefit-risk profile of new medicines.