ABSTRACT
Other applications of B-R assessment in early development stem from its potential to serve as a structural link between a target product profile (TPP) and the clinical development plan, its utility in contributing to internal “stage gate” decisions, and its use in suggesting minimally important effect sizes or rates needed for benefits to outweigh harms. As health authorities continue to advance proposals for structured approaches toward benefitrisk,1,5,10 sponsors will increasingly need to get an earlier start on preparing their study designs and analyses to support these growing requirements.
