The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples including Regulatory Buy-in

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  • The Genesis of Estimands: A conversation in 2017 that led to the creation of the Estimands Framework, a shared language to simplify complexity in clinical trials.
  • A Closer Look at Depression Studies: Me and Elena strategically chose depression as their focus for research due to its unique challenges, including efficacy, maintenance, intercurrent events, and time-to-event endpoints.
  • The Practical Guide: A collaborative effort between stakeholders has produced a practical guide to help study teams better understand and utilize the Estimands process for clinical trial design.
  • Regulators on Board: Getting the support and validation of regulatory bodies was an essential factor in the success of the Estimands Framework.
  • A Blueprint for Progress: The Estimands Framework, developed by me and Elena, enhances the pharmaceutical industry by providing a path towards greater precision, clarity, and collaboration in clinical trials.

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About this podcast

The podcast from statisticians for statisticians to have a bigger impact at work. This podcast is set up in association with PSI - Promoting Statistical Insight. This podcast helps you to grow your leadership skills, learn about ongoing discussions in the scientific community, build you knowledge about the health sector and be more efficient at work. This podcast helps statisticians at all levels with and without management experience. It is targeted towards the health, but lots of topics will be important for the wider data scientists community.

by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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