Why Estimands are Relevant in Clinical Research white paper

Why estimands are relevant in clinical research

Discussing application of estimands in clinical research including clinical pharmacology trials

Clinical trial protocol development can be complex, and objectives can sometimes be unclear. In early protocol planning it is important to be transparent about the scientific question of interest – the estimand – which is a precise description of the treatment effect the research should summarize.

This white paper discusses:

• Why estimands are relevant in clinical pharmacology trials
• Key steps in the estimand thinking process
• The value of estimands in helping to identify and clarify research goals
• The growing use of estimands in clinical trial protocols following the release of new regulatory guidance