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31.03.2021

Addendum ICH E9 (R1) zur ICH E9 Statistik-Guideline für eine klinische Prüfung

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.

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

To learn more on the topic watch an interview Kristina Bondareva on the ICH E9(R1) Addendum on Estimands and Sensitivity Analysis and the role of biostatistical analysis in clinical research.

 

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