Media Room

25.03.2021

Webinar on Biostatistics: 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.

Bringing clarity to the concept of estimands and the key issues debated in E9(R1) will help industry experts to understand their purpose and impact on study design, statistical analyses and the study outcome.

The European Medicines Agency (EMA) adopted the E9(R1) addendum on estimands and sensitivity analysis in clinical trials effective July 30 2020. The E9 (R1) addendum presents a framework for defining an appropriate estimand for a clinical trial. OCT Clinical invites you to attend the webinar “E9(R1) Addendum on Estimands and Sensitivity Analysis. Considerations for Successful Implementation”, which is focused on considering the impact of, and documenting relevant intercurrent events within the estimand framework.

The webinar will be hosted by Kristina Bondareva, the Head of Biostatistics at OCT Clincal.

During the webinar you will learn about:

  • Concepts of “Estimand” and “Intercurrent events”
  • 5 strategies for addressing intercurrent events
  • How a study objective can be translated into an appropriate estimand definition
  • Consideration for analysis and missing values under different strategies
  • Reflection of the new estimand framework in specific guidelines in the therapeutic area

Who will benefit:

  • Medical officers
  • Scientific officers
  • R&D
  • Biostatisticians and medical writers
  • Regulatory managers
  • Clinical operations
  • Clinical trial management

Learn more here 

Register for the event:

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