Statistical Consulting offer comprehensive expertise on the design and implementation of estimands in clinical trials. Using our in silico clinical trial simulation tool, KerusCloud, we can prospectively factor in different estimands for review and quantification of the impact on the probability of success of a trial.
Estimands were implemented in the ICH E9 (R1) addendum in 2019, and are a structured framework to facilitate alignment of the clinical trial objectives, design, conduct, analysis and interpretation. It also ensures transparency of the objectives from different stakeholders (e.g. regulators, payors, sponsors and patients). The ultimate goal is to make sure that clinical trials provide clearly defined information on the effects of the investigative treatments.