You will be guided through a case study (CheckMate 037) and interactively deepen the knowledge to gain hands-on experience in developing estimands. You will be introduced to the background and disease context of the case study, the concept of an estimand, and important clinical events (increased dropout rate and crossover therapy) that occurred in the trial and affected interpretation of the results. Using non-technical language and clear graphical presentation of the concepts, you will experience how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials. Target audience (no prior knowledge in oncology or of estimands required): Clinicians, Investigators, Regulatory Experts, Medical Writers, Ethics Committees, Statisticians.
The targeted learning outcomes are as follows: - Recognize the benefits of following the estimand framework (ICH E9 (R1) addendum) in the context of a clinical trial, in order to: - have a common language to describe the diversity of patient journeys - address the right question in clinical trials - Be able to construct an estimand, including identification of relevant intercurrent events and application of relevant strategies to address them - Gain insights from a cross-industry international working group on estimands in oncology Presented by members of the Estimands in Oncology special interest group
www.oncoestimand.org
Contents
05:33 Learning Outcomes
06:30 Introduction to the case study
15:55 Intermezzo - Comic
17:20 Estimands in Oncology - How and Why
17:20 ICH E9 (R1) Estimand Framework
21:40 Five Components of an Estimand
25:15 Five Strategies for Intercurrent Events
42:43 Revisiting the case study
45:00 Estimand for the primary analysis
47:21 Estimand for the post-hoc analysis
49:20 Interactive quiz with Q&A
1:18:40 Concluding Remarks
1:20:30 General Q&A
