Centre for Medicines Research Health Canada, Australia's Therapeutic Goods Administration, SwissMedic and Singapore Health Science Authority

1. Description

The CMR CASS framework was initially described in a paper by Stuart Walker in 2008, [1] but the framework has been succeeded by COBRA.

2. Evaluation

  • CMR CASS's ultimate goal was to develop an approach which is universal, quantitative, lifecycle covered, and flexible with various stakeholders. The important points being considered and tested within CMR CASS are:
  • a universal framework for every parties is the target and a quantitative BR model is the ultimate goal;
  • the changes in benefit risk balance need to be accommodated and benefit-risk assessment should be revisited through the product life-cycle;
  • the development of the framework needs the involvement of a wide range of stakeholders;
  • the challenges in assessing benefit and risk in post-approval phase are to be tackled

3. References

[1] Walker S, McAuslane N, Liberti L, Salek S. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. Clin Pharmacol Ther 2009 Mar;85(3):241-6.