Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples including Regulatory Buy-in
- Author
- Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
- Published
- Mon 06 Nov 2023
- Episode Link
- https://podcastae8fac.podigee.io/315-new-episode
Interview with Elena Polverejan
- 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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