Structured Benefit–Risk Assessment of Medicinal Products
This self-paced course will provide an understanding of current techniques, opportunities and challenges of structured benefit risk assessment including different preference elicitation techniques.
The evaluation of the benefit–risk balance is a key element across the entire life cycle of a medicinal product. Intuitive, implicit benefit–risk assessment methods have evolved towards more structured approaches. A structured benefit–risk assessment aims at providing a transparent assessment of the benefit–risk profile of medicinal products by making explicit the underlying assumptions and value trade-offs. Several quantitative and semi-quantitative methodologies have been developed and utilized to complement descriptive or qualitative frameworks in order to facilitate the structured evaluation of the benefit–risk profile of medicinal products.
Although combining key benefits and risks into a single metric have historically only been conducted for the “average” patient, such aggregate assessments may also provide helpful information on the level of an individual patient. Furthermore, there is an increasing interest on the use of real‐world data to substantiate benefit–risk assessment and support a more patient-centered approach and the value of a new treatment options in daily practice. The course is therefore intended for anyone who wishes to extend their knowledge on structured benefit risk assessment with a specific focus on multi-criteria decision analysis, from prescribing physicians to industry, regulatory and other professionals.
The course consists of three self-paced learning units, starting with an introduction to benefit-risk, followed by learning units on decision making styles and multiple-criteria decision analysis. After the course, participants are asked to complete a final assignment, in which they will conduct a benefit-risk assessment. The course takes on average 20 hours to complete.
An overview of the learning units of this course:
- Introduction to Benefit-Risk Assessment
- Decision Making Styles
- Multiple-criteria Decision Analysis
- Final Assignment