[Webinar] ICH E9(R1) Addendum on Estimands and Sensitivity Analysis

Discover how the new framework will improve the way of designing and planning clinical trials and performing primary analyses and sensitivity analyses.

The European Medicines Agency (EMA) adopted the E9(R1) addendum on estimands and sensitivity analysis in clinical trials effective July 30 2020. Bringing clarity to the concept of estimands and the key issues debated in E9(R1) will help to understand their purpose and impact on study design, statistical analyses and the study outcome.

During the webinar you will learn about:
00:00 ICH E9(R1): How it all started
3:39 Estimands and intercurrent events
5:19 5 strategies for ICEs
10:13 Defining an Estimand
12:53 Aligning target of estimation, method of estimation, and sensitivity analysis, for a given trial objective
13:56 Considerations for Analysis: Treatment Policy
14:37 Considerations for Analysis: Composite Strategy
17:03 Considerations for Analysis: Hypothetical Strategy
18:46 Considerations for Analysis: While on Treatment
19:30 Considerations for Analysis: Principle Stratum
19:53 Estimands in Therapeutic Area Guidelines: Diabetes
22:27 Implementation in Semaglutide Studies
23:41 Estimands in Therapeutic Area Guidelines: Crohn’s Disease
24:24 Example: Rheumatoid Arthritis (Ratitch et al., 2020)
30:03 Concluding Notes

The webinar is hosted by Kristina Bondareva, the Head of Biostatistics at OCT Clinical.


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