MES: Benefit-Risk Assessment Frameworks

As part of the European Medicines Agency (EMA) Benefit-Risk project, the PrOACT-URL framework was adapted for use in benefit-risk assessment of medicinal products, and the Work Package 3 conducted field tests, and conclude with a list of proposals for endorsing the framework, as an adjunct to current CHMP processes, including “adopting the PrOACT-URL framework to guide the process of evaluating the benefit-risk balance” …

Mini Educational Series: Planning a benefit-risk assessment using frameworks


Frameworks are needed to plan a benefit-risk assessment. Although it may be clear to some people that certain framework has been used when conducting a BRA, it may not be clear to others. In particular, when non-standardised frameworks such as internal (company-specific) frameworks are used.

It is not that these frameworks are not acceptable, but they are more difficult to follow by individuals who do not have access to the detail of the process. Therefore, the use of such frameworks may be seen as a black box to those in the unknown.