Who is this event intended for?:

Clinical Statisticians who wish to facilitate the effective implementation of the estimand framework in clinical trial protocols, and understand the challenges in design, data collection, estimation and reporting.

Due to the interactive nature of this online workshop, there are a limited number of places so please apply quickly to avoid disappointment. Whilst the estimand framework can apply to any phase of clinical trial, we will focus mostly on Phase 2 and 3.

What is the benefit of attending?:

Since the implementation of ICH E9(R1), estimands have become a critical foundation to the development of clinical trials. Delegates will gain experience of applying the estimand framework to real case studies. The training will give an opportunity to discuss estimands with experts from the estimand implementation working group (EIWG) and gain the skills to discuss and apply the estimand framework to their own studies.

Brief event overview:

This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.

Full overview:

Experts from the Estimand Implementation Working Group (EIWG) will provide an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum. Case studies will be discussed illustrating the implementation of this framework in a variety of settings and therapeutic areas, and equivalence, non-inferiority and superiority goals. Insights into the best practice for handling intercurrent events in data will be provided by the PHUSE Implementation of Estimands using Data Standards Project Team.

In addition, we will engage delegates through considering how estimands might apply to their own clinical settings, interactive quizzes and break out rooms for team discussions of a case study. To get the most from this training, delegates should be prepared to switch on cameras for discussions and complete some tasks between sessions. Team discussions will be supported by EIWG tutors.

There will be a coffee and lunch break on each day. Further information can be found in the agenda below.