UMBRA (Unified Methodologies for Benefit-Risk Assessment)

1. Description

UMBRA brings together the smaller initiatives such as COBRA, PhRMA BRAT and SABRE to establish a unified framework containing common elements across different methodologies for benefit-risk assessment. The current framework model currently proposed by UMBRA contains eight steps within four stages.

2. Evaluation

UMBRA has released an early version of a benefit-risk "proforma", which is based on the following stages and steps:

Stage 1: Framing the decision

  • Step 1: Decision context

Stage 2: Identifying benefits and risks

  • Step 2: Building value tree
  • Step 3: Refining the value tree

Stage 3: Assessing benefits and risks

  • Step 4: Relative importance of benefits and risks
  • Step 5: Evaluating the options

Stage 4: Interpretation and recommendations

  • Evaluating uncertainty
  • Concise presentation of results (visualisation)
  • Expert judgement and communication

The proforma is developed as a PDF form, which is easy to use and contains standardised fields. The usability of the proforma is yet to be tested widely in real-life benefit-risk assessments of medicines.

3. References

[1] CIRS Website.
[2] CIRS Workshop Synopsis on Benefit-Risk. 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? Washington, DC, Centre for Innovation in Regulatory Science.