|Carl Di Casolifirstname.lastname@example.org|
The benefit-risk assessment of a new medicinal product or intervention is one of the most complex tasks that sponsors, regulators, payers, physicians, and patients face. Therefore, communicating the trade-off of benefits and risks in a clear and transparent manner, using all available evidence, is critical to ensure that the best decisions are made. Several quantitative methods have been proposed in recent years that try to provide insight into this challenging problem. Bayesian inference, with its coherent approach for integrating different sources of information and uncertainty, along with its links to optimal decision theory, provides a natural framework to perform quantitative assessments of the benefit-risk trade-off.
- 1. The next project is a technical article aimed at a statistical audience which provides more granularity on specific approaches and how to apply them, as well as some case studies to share experiences of using them in practice.