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.
The full thesis can be downloaded at :
https://dspace.library.uu.nl/bitstream/1874/424348/1/proefschrift%20-%2063886b7f9ebfb.pdf
https://dspace.library.uu.nl/handle/1874/424348
https://dspace.library.uu.nl/bitstream/1874/424348/1/proefschrift%20-%2063886b7f9ebfb.pdf
https://dspace.library.uu.nl/handle/1874/424348