Expert Insights Webinars

The ICH E9(R1) Addendum on 'Estimands and Sensitivity Analysis in Clinical Trials' 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. 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. 

Key Takeaways

• The estimand framework according to the ICH E9(R1) Addendum 
• Strategies for addressing intercurrent events when defining the clinical question of interest 
• Why clinicians and statisticians need to work closely together to describe the treatment of interest 
• How to create a framework that is clinically meaningful and can be estimated robustly and with minimal assumptions at trial end 

Who Will Benefit from Attending?

Speaker

Frank Bretz joined Novartis in 2004, where he is currently a Distinguished Quantitative Research Scientist. He has supported the methodological development in various areas of pharmaceutical statistics, including adaptive designs, dose finding, estimands, and multiple testing. Frank is currently holding adjunct professorial positions 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'. Among other professional services, he is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the past editor of Statistics in Biopharmaceutical Research.

Moderator

Kevin Chartier has more than 25 years of experience in the pharmaceutical industry across various statistics, biometrics, and biostatistics functions.

As Principal Advisor of Biostatistics and Submissions Planning, Kevin works with the biostatistics team across MMS global operations to support Sponsors with complex studies, programs and submissions across various therapeutic areas and extending to rare diseases. In addition, he acts as the senior technical reviewer for complex biostatistics studies and advises Sponsors on biostatistics methods and efficiencies for health authority submissions.