Benefit-risk assessment is a crucial step in evaluating the safety and efficacy of medical products. Quantitative benefit-risk assessment (qBRA) is a set of techniques that can help drug and medical device developers and regulators to evaluate the benefit-risk balance of medical products.
This report outlines five main steps for developing qBRAs. The first step is to identify the research question and specify the role of external experts. The second step involves developing a formal analysis model by selecting benefit and safety endpoints, eliminating double counting, and considering attribute value dependence. The third step is to choose a preference elicitation method, frame attributes appropriately, and evaluate the quality of the data. The fourth step involves normalizing preference weights, conducting base-case and sensitivity analyses, and analyzing the effect of preference heterogeneity. Finally, the fifth step is to communicate the results efficiently to decision makers and other stakeholders.
In addition to these steps, ISPOR provides a checklist for reporting qBRAs. By following these emerging good practices, drug and medical device developers and regulators can better evaluate and communicate the benefit-risk balance of medical products.
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