Synergy in Action

Estimands and Missing Data Working Group Activity / Deliverables

Chairs: Elena Polverejan, PhD; Lorenzo Guizzaro, MD, PhD

Most Recent Activity: Working Group Session – 19th Annual Scientific Meeting – 15-17 February 2023, Washington DC – View Summary
While the ICH E9(R1) Addendum on “Estimands and Sensitivity Analysis in Clinical Trials” was released in 2019, the widespread implementation of defining and reporting estimands across all clinical trials is still in progress and the engagement of non-statistical functions in this process is still to be fully experienced. The ISCTM Estimands and Missing Data Working Group (WG) consists of both clinicians and statisticians from FDA, EMA and the Pharma Industry. This working group developed an interdisciplinary process for implementing the estimand framework, which was illustrated by examples using hypothetical trials evaluating a treatment for major depressive disorder (MDD). In this session, the WG will share and discuss with the participants the process of implementing the estimand framework and several of the MDD examples. This work is included in a manuscript that the WG has put together. Discussions will also be initiated on the future plans of this WG, including what CNS disease area to explore beyond MDD.

Current Deliverable: Manuscript submitted – Title: Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples Based on a Psychiatric Disorder

Most Recent Activity:
Working Group Session – 18th Annual Scientific MeetingView Slides – 23-25 February 2022, Washington DC
Working Group Session – 17th Annual Scientific Meeting-View Summary– 7 April 2021, Virtual
Working Group Session – 16th Annual Scientific Meeting-View Summary– 19 February 2020, Washington DC
Working Group Session – 15th Annual Scientific Meeting- View Slides – 19 February 2019, Washington DC
Working Group Session – 14th Annual Scientific Meeting-View Summary  – 20 February 2018, Washington DC
13th Annual Meeting – 21 February 2017 – Washington DC
Inaugural Working Group Session
Working group session was borne out of the Missing Data session presented at the 2016 Autumn Conference-View Meeting Presentations/Videos

Link to Estimands & Missing Data Project Materials