Estimands in clinical drug development: from design to regulatory assessment - PhDData

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Estimands in clinical drug development: from design to regulatory assessment

The thesis was published by Mitroiu, Marian, in December 2022, Utrecht University.

Abstract:

In this thesis, I investigated the (implicit) use of estimands in the pre-estimand era in clinical trials for regulatory evaluation and approval to understand what estimands may correspond to efficacy investigations and common efficacy analyses. Additionally, I developed data-generating models (DGMs) that take into account the association between clinical outcomes and intercurrent events.



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