Estimand framework: Delineating what to be estimated with clinical questions of interest in clinical trials

ICH (International Council for Harmonization) E9 R1 (2019) proposes a framework to define estimands in clinical trials. Although the concept of estimand was proposed previously when US Food and Drug Administration (FDA) issued the panel report on handling missing data in clinical trials, many details including attributes and different strategies have not been developed until the recent ICH E9 (R1) addendum. A clearly defined estimand should include considerations of five attributes including patient population, treatment regimen of interest, endpoint/variables, handling of intercurrent events (IEs), and summary measures for assessing treatment effect.
Source: Contemporary Clinical Trials - Category: Radiology Authors: Source Type: research