The SSA and the Australian Pharmaceutical Biostatistics Group (APBG) proudly offer this two day workshop,
The ICH E9(R1) Addendum on 'Estimands and Sensitivity Analysis in Clinical' introduced a framework to align planning, design, conduct, analysis, and interpretation of clinical trials. When defining the clinical question of interest, clarity is needed about 'intercurrent events' that affect either the interpretation or the existence of the measurements associated with the clinical question of interest, such as discontinuation of assigned treatment, use of an additional or alternative treatment and terminal events such as death. The description of an estimand should reflect the clinical question of interest in respect of these intercurrent events, and the Addendum introduces strategies to reflect different questions of interest that might be posed.
This two-day course will introduce the estimand framework according to the ICH E9(R1) Addendum. Using a generic example to illustrate the thinking process that aligns estimands and sensitivity analyses with trial objectives, we will provide an in-depth description of intercurrent events and various strategies for addressing them when defining the clinical question of interest. The choice of strategies can influence how more conventional attributes of a trial are reflected when describing the clinical question, for example the treatments, population or the variable (endpoint) of interest. For a given estimand, an aligned method of analysis, or estimator, should be implemented that is able to provide an estimate on which reliable interpretation can be based and which includes the handling of intercurrent events, missing data and sensitivity analyses. We will therefore also discuss how to identify and implement analyses approaches as well as sensitivity analyses that are aligned with a chosen estimand for different types of endpoints in longitudinal clinical trial settings.
Course Outline
This two-day short course will include eight lectures (one hour and 30 minutes for each), with four lectures on Day 1 (October 20) and four on Day 2 (October 21).
Day 1:
. Introduction, motivation and scope of the ICH E9(R1) Addendum
. A framework to align planning, design, conduct, analysis and interpretation of clinical trials
. Description, strategies and construction of estimands
. Generic example to illustrate the thinking process that aligns estimands and sensitivity
Day 2:
. Gentle introduction to causal inference
. Intercurrent events and missing data
. Main analyses targeting estimands for different types of endpoints and strategies
. Sensitivity and supplementary analysis in light of the estimand framework
Learning Objectives
This course will focus on estimands and related statistical methodologies that are commonly used in clinical trials. We will share our experiences and try to provide some guidance on their use in clinical trial practice. The target audience includes statisticians working in industry (pharmaceutical companies), academia (universities, medical centers, or research hospitals), or government (AIHW/TGA), and also graduate students who are interested in clinical trial methods. The difficulty level of the course is intermediate, at a second-year graduate course
level.
The learning objectives are three-fold: (1) to understand the fundamentals of the estimand framework and be able to apply it in clinical trials; (2) to identify an appropriate primary analysis method that targets the estimand of interest, fully aligned with the ICH E9(R1) Addendum; and (3) to implement appropriate main and sensitivity analyses.
Catering will be including: Arrival Coffee, Morning tea, Lunch and
Afternoon tea.
Presenter Biography
Dr. Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has supported the methodological development in various areas of pharmaceutical statistics, including dose finding, multiple comparisons, estimands, and adaptive designs. Frank is an Adjunct Professor at the Hannover Medical School (Germany) and the Medical University of Vienna (Austria). He was a member of the ICH E9(R1) Expert Working Group on 'Estimands and sensitivity analysis in clinical trials' and currently serves on the ICH E20 Expert Working Group on 'Adaptive clinical trials'. Frank is a Fellow of the American Statistical Association.
Cancellation Policy
Cancellations received prior to Friday,October 14, 2022 will be refunded, minus a $20 administration fee. From then on wards no part of the registration fee will be refunded. However, registrations are transferable within the same organisation. Please advise any changes to events@statsoc.org.au.
@StatSocAus
