Online Program

Clinical Perspectives on Estimand Framework Implementation (303517)

*Miya Okada Paterniti, US Food and Drug Administration 

Keywords: estimands

The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials was finalized in November 2019 and is being implemented by many regulatory agencies, including FDA. Multidisciplinary engagement is critical to successful implementation of estimand frameworks. In this presentation, I will provide a clinical perspective on the implementation of the estimand framework. Topics will include the benefits of productive interdisciplinary collaboration, challenges of implementation of the estimand framework, and examples of estimand frameworks.