PAGE. Abstracts of the Annual Meeting of the Population Approach Group in Europe.
PAGE 26 (2017) Abstr 7413 [www.page-meeting.org/?abstract=7413]
Click to open
Oral: Benefit-Risk assessment
Overview/Description of presentation: Industry’s use of quantitative benefit-risk assessment (BRA) has recently received stimulus from an increased interest in its use by the FDA. Most BRA is thus undertaken by industry alongside phase 3 trials. However, there is increasing interest in undertaking BRA earlier in the development process, incorporating BRA into model-based approaches to informing the design of trials. This will allow the assessment of trial design scenarios to be based on models of the probability of achieving regulatory approval.
The presentation will be organised into four sections:
Conclusions/Take home message: Quantitative BRA is increasingly being used to support approval in the US. Anticipating this requirement, it is possible to incorporate quantitative BRA into model-based approaches to trial design.