Strategies for Navigating ICH E9(R1): Considerations for Using Estimands and Sensitivity Analysis in Clinical Trials

What You Will Learn

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. 

Attendees will learn about:

• 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 

What You Will Learn

Biostatistical, clinical and regulatory affairs professionals contemplating study design and statistical analysis for clinical trials and clinical development programs