Keywords: Estimand Oncology time-to-event causality
A draft addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in August 2017 and introduced an estimand framework. The new framework aims at aligning trial objectives and statistical analyses by requiring a precise definition of the population quantity of interest, the estimand.
An industry working group for estimands in oncology was formed in February 2018 with members cross-industry to ensure common understanding and consistent definitions for key time-to-event estimands in Oncology. Representative of the causal subteams of the working group, this talk will discuss causality in a time-to-event setting with examples where a causal estimand in a drug development program is desirable. This talk will cover principal stratification and discussion of causal estimand under alternative summary measures, in the estimand framework under causality considerations, and their underlying assumptions and possible implication on drug development.