Overview

The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.

GRADUATE I(NCT03444870) and GRADUATE II (NCT03443973) were two global, Phase III, randomized, placebo-controlled trials assessing the efficacy and safety of gantenerumab in early Alzheimer's disease. The GRADUATE studies were among the first pivotal trials in Alzheimer's Disease to adopt the estimand framework and to conduct a primary analysis which is fully aligned with the targeted estimand.

In this webinar we will review the key elements of the estimand framework through the experience of the Graduate study team. We will review how the Graduate study team interpreted the estimand framework and used its elements to cover the primary clinical question of interest. We will review the challenges we met and the solutions we implemented.

This webinar will be interactive. Questions will be raised at different points during the talk and we will end with 30 minutes dedicated to answer open questions.

Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Health technology assessors, Statisticians.

What is the benefit of attending?

● To illustrate the purpose of each estimand attributes using simple language in a pivotal study in early Alzheimer's disease

● Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to:

- gain alignment on the question(s) of interest

- frame questions which may be of interest to different stakeholders

- be transparent when communicating trial results

Timings

14:00-15:30 BST | 15:00-16:30 CEST