DIA/FDA Statistics Forum 2014

Drug development and regulatory decision-making have long been guided by informal weighing of the benefits and risks of medical treatments. Due in part to new regulatory initiatives, formal benefit-risk assessments are increasingly important to industry and regulatory stakeholders. Statisticians play a key role in benefit-risk assessment, helping to develop and implement explicitly quantitative benefit-risk methodologies, as well as providing input to more qualitative approaches. In this session, we will hear from three benefit-risk experts: an FDA representative, who will provide an overview of the current regulatory environment for benefit-risk assessment and ongoing initiatives; a member of the QSPI Benefit-Risk Working Group, who will discuss existing methodologies for benefit-risk assessment; and a representative from industry, who will present a case study applying a benefit-risk assessment in a regulatory filing.