Benefit-risk assessment is used to weigh up the benefits of a specific treatment with the risks of that treatment. It is a process that should be continuously reviewed throughout the lifecycle of a drug.
The DSRU team conducts benefit-risk assessments on medicines at the stage of marketing authorisation (see publication below). Our bespoke protocols are designed to satisfy regulatory requirements and answer any specific questions from the European Medicines Agency or other regulator.
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- A systematic benefit-risk assessment is a useful tool to strengthen the ongoing monitoring of a treatment’s benefit-risk balance, by determining if the benefit-risk profile is considered favourable
- Semi-quantitative methods standardise and support the decision and communication of a benefit-risk assessment to regulatory authorities
- One example of a framework that can be used is the Benefit-Risk Action Team (BRAT) framework, which follows the structured format of a qualitative framework but allows flexibility in choice of quantitative assessment
- BRAT was specifically designed to assist communication with regulatory authorities and the framework design ensures that the decision-making process is transparent
- Benefit-risk assessments can be conducted in a relatively short timescale (within 3 months), where all data on benefits and risks are available
BMJ Evidence-Based Medicine Published Online First: 24 February 2020. doi: 10.1136/bmjebm-2019-111295