Alira Health

Alira Health

Considerations on the Use of Estimands Within the Integrated Summary of Effectiveness and Integrated Summary of Safety, and Benefit/Risk Analysis

White Paper

The number of scientific publications emerging on estimands is increasing year over year. However, the current discussion on estimands mainly focuses on efficacy evaluation in individual clinical studies. There is little discussion and no specific guideline on estimands in the context of safety assessments and integrated analyses.

This paper shares the pharmaceutical industry experience in implementing the estimand framework in the first two years since the final guidance on estimands became available.

Download this white paper to learn more about the use of estimands in the field of Integrated Summary of of Effectiveness and Safety, and benefit/risk analyses. Key lessons learned, emerging best practices, and points to consider on strategies for implementing the new estimand framework are provided.

Estimands within Integrated Summary of Efficacy and Safety

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