Дополнение ICH E9 (R1) к руководству ICH E9 «Статистические принципы для клинических исследований»

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.

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