Decisions throughout the medical product lifecycle are informed by benefit-risk assessment (BRA), including marketing authorization and surveillance, health technology assessment, and clinical decisions. All BRAs involve examination of the decision context, specification of benefits and risks for treatment options, and judgement about the acceptability of benefit-risk trade-offs within the decision context. In some cases, the benefit-risk balance of a product is unclear and quantitative BRA (qBRA) can add value and supplement a qualitative, descriptive BRA. Such analyses integrate trade-off preference data with evidence on product performances using an evaluation framework (e.g., multi-criteria decision analysis), to perform an overall assessment of individual benefit-risk profiles. The ISPOR Task Force on emerging good practices in qBRA developed guidance on how to conduct and report a scientifically rigorous qBRA.

In this Forum, we will present the Task Force’s final recommendations. To begin, we will briefly review the history of qBRA, including recent examples of use by regulators (Lackey – 15 mins). Then the task force will present our final recommendations for conducting and reporting qBRA in five steps: formulating the research question, developing a model, eliciting preferences, conducting analysis, and communicating results, together with a case study (Ho – 15 mins). Following this, we will describe how the qBRA is practically implemented in industry (Mauer – 15 mins). Through polling we will gather audience reactions to the recommendations and discuss future areas of research related to qBRA (Tervonen – 15 mins). Researchers conducting qBRA as well as decision-makers utilizing the results of qBRA will benefit from attending.