Synergy in Action

16th Annual Meeting Abstract: Is there a fundamental rethinking in the way we plan clinical trials? The estimand change in mindset

Chairs:  Pilar Lim PhD; Michael Davis MD; Steve Brannan MD

The final ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” has been released in November 2019. It provides significant impact on the planning of clinical trials, requiring a change in mindset. The Addendum proposes a framework for treatment effects to be more precisely specified, this way facilitating discussions between sponsors and regulators. Regulatory agencies are adopting the estimand framework, increasing the number of requests on estimand selection. This has an impact on the design and conduct of new trials and on answering regulatory questions for ongoing programs. This guidance has an impact on the work of all members and functions of ISCTM.

This session will describe the framework recommended by the final ICH E9(R1) Addendum. The ISCTM working group on Estimands and Missing Data will share their experience in devising a structured process that could be used by clinical teams when planning a clinical trial according to the ICH E9(R1) guidance, with estimand examples from Major Depressive Disorder. Regulatory views on the implementation of this guidance will be provided, reflecting the implications of the estimand framework.