People familiar with the design, conduct and analysis of clinical trials understand efficacy endpoints, study populations, and their analyses, however the term estimand is not familiar to most non-statisticians. While many sponsors are moving forward and implementing ICH E9 R1 and estimands into their protocols, some sponsors have yet to understand or incorporate the components of an estimand in their trial design. By understanding (and implementing) estimand frameworks, the process of identifying the question of interest is facilitated, the target objectives are aligned with the clinical trial design, and future problems in interpretation of the results can be potentially avoided.

The final definition of an Estimand in ICH E9 R1 is “A precise description of the treatment effect reflecting the clinical question posed by the trial objective. It summarizes at a population-level what the outcomes would be in the same patients under different treatment conditions being compared."

What is needed is a way to simplify and effectively communicate the key concepts around the use of estimands and sensitivity analyses to non-statisticians.

This presentation will review fundamentals of estimand frameworks for those involved with developing clinical trial protocols. Example estimands pertaining to different indications will be reviewed. The presentation will also suggest ways to improve understanding of estimands as statisticians communicate the concepts of ICH E9 R1 to non-statisticians.