All Times EDT
Keywords: Estimands, Oncology, Causal
The ICH E9 (R1) guidance on estimands and sensitivity analysis was finalized by the FDA in May 2021. The Pharmaceutical Industry Working Group on Estimands in Oncology has been continuing to review and refine key clinical trials issues in light of the estimands framework. This panel discussion addresses some of the work the Working Group’s task forces has been engaging in to look more closely at issues common in oncology trial design. Question we'll discuss include:
How can we encourage consistent analysis and interpretation of Duration of Response and Time to Response in clinical trials?
What is the clinical question of interest if patients receive the option of subsequent therapy?
How does concern about causal estimands impact the way we do time to-event trials?
What do we mean by follow-up time in a clinical trial?