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? http://cirsci.org/system/files/private/CIRS_June_2012_Workshop_Synopsis.pdf. 20-6-2012. Washington, DC, Centre for Innovation in Regulatory Science.