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

• 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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