Benefit-risk assessment is used to weigh up the benefits of a specific treatment with the risks of that treatment. The DSRU team has just published a report on a systematic benefit-risk assessment conducted to compare the benefits and risks of a new mode of delivery of an existing drug with that of the well-established tablet/ film formulation. This key publication explains how a semi-quantitative benefit-risk method is used to support risk management.
The paper, “Systematic benefit-risk assessment for buprenorphine implant: a semi-quantitative method to support risk management”, reports on a benefit-risk assessment conducted by the DSRU to determine whether a new version of buprenorphine (an implant) has a favourable profile compared to the existing version of the drug (a sublingual tablet placed under the tongue). Buprenorphine is used to treat opioid dependence. The systematic benefit-risk assessment was required prior to approval in the EU as part of the licence application to the EMA.
In this case, the Benefit-Risk Action Team (BRAT) framework was used, which follows the structured format of a qualitative framework but allows flexibility in choice of quantitative assessment.
Further information about our capability to conduct benefit-risk assessment is available here.
If you would like to speak to a member of the DSRU team regarding a possible benefit-risk assessment, please contact us.