Estimand Strategies in Early Phase Clinical Research – A Case Study in Type 2 Diabetes

Estimand strategies are crucial in modern clinical research, offering a structured framework to define treatment effects by aligning study objectives with trial design and analysis. Introduced in the ICH E9(R1) addendum, estimands clarify how to handle complexities such as treatment discontinuation and rescue medication use, thereby enhancing trial transparency and relevance for stakeholders. Initially emphasized in Phase III trials, estimand strategies are gaining popularity in early phase trial protocols to improve decision-making and dose selection.
To learn more about strategically positioning estimands in your clinical development pathway, read our in-depth article, which explores their applications and benefits in early phase investigations.