Methodologies

Several organisations have been developing specific methodologies for the assessment of a medicine’s benefits and risk.  These include activities at the EMA, US FDA and through the CIRS COBRA initiative with Swissmedic, Health Canada, HSA Singapore, and TGA Australia. In addition, pharmaceutical companies are exploring novel approaches to the assessment, visualisation and communication of these data through activities initiative under the auspices of the Pharmaceutical Research and Manufacturers of America (PhRMA) Benefit-Risk Action Team (BRAT).  In 2011, CIRS was selected by PhRMA to further the evolution of the work pioneered by the PhRMA BRAT and to broaden input from the scientific community into the evolution of this methodology. 

 Under the auspices of the UMBRA Initiative, it is envisioned that best-in-class components of these initiatives will be used to develop novel methodologies for use in the evaluation of specific therapeutic products during all phases of a medicine’s development and life cycle. The approaches listed under Regional Initiatives are some of the more well-developed approaches to benefit-risk assessment.