All Times EDT
Keywords: benefit-risk assessment, estimands, safety estimand
While much has been written and discussed regarding estimands targeting benefit (efficacy, effectiveness), a more limited engagement of estimands targeting risk (safety), and the subsequent implications for benefit-risk assessments, has emerged. In light of the desire to achieve transparent and reliable benefit-risk assessments, the utilization of an estimand framework for key safety events, when aligned with estimands targeting benefit, may support those goals, as well as support a more homogenous use of language across benefit and risk analyses.
Questions that will be explored during this roundtable include:
• In what ways could leveraging the estimand framework for key safety analyses support the standardization of analyses and associated language? • Is the estimand framework appropriate or necessary for key safety analyses? • In what ways should intercurrent event handling strategies align across estimands targeting benefit and those targeting risk?