Patient-focused Benefit-risk Assessment
*Bennett Levitan, Janssen Research & Development at Johnson & Johnson 


A growing number of industry, health authority and patient-driven initiatives have been paving the way towards engaging patients in the medical treatment development and regulatory review. A major focus has been on assessing the relative importance, or preferences, that patients place on the benefits, harms and other aspects of treatment. This presentation will introduce key elements of one such initiative, the Medical Device Innovation Consortium’s Patient-Centered Benefit-Risk Framework, including (i) the nature of preference sensitive decisions, (ii) the type of regulatory situations where patient preference information is potentially valuable, (iii) the utility of different approaches to preference assessment at different points in the development lifecycles and (iv) the notion of approval for a subgroup of patents defined by benefit-risk preferences. We will show examples of how preference information can be used to inform development strategy and support a transparent and defensible benefit-risk assessment.