COBRA (Consortium On Benefit-Risk Assessment)

1. Description

COBRA succeeded CMR-CASS coinciding with the establishment of the UMBRA Initiative. COBRA develops a framework "proforma" to standardise benefit-risk assessment.

2. Evaluation

COBRA takes a more qualitative approach (semi-quantitative) to benefit-risk assessment. The "proforma" template is being improved:
  • to reflect more of the actual practice;
  • to integrate visualisations of data.

The template is to have the following features:
  • can auto-populate the information
  • being a qualitative approach (or semi-quantitative)
  • contains a summary section
  • contains a proforma section
  • considers uncertainties
  • addresses benefit-risk management
  • contains explicit decision

3. References

[1] 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? 20-6-2012. Washington, DC, Centre for Innovation in Regulatory Science.