Artikel
Estimand in Huntington's Disease
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Veröffentlicht: | 26. Februar 2021 |
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Gliederung
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In this talk, we will discuss the primary estimand framework for a Phase III study in Huntington's disease, which uses a continuous endpoint as a primary outcome. While the definition of each attributes will be described, particular focus will be given to intercurrent events, including their identification and handling strategies. In addition to the primary estimation method, methods for missing data imputation and sensitivity analyses assessing the robustness of the estimator will also be discussed. Supplementary estimands to address slightly different clinical questions of interest will also be investigated. Finally we will summarize some practical considerations and challenges encountered during the process of developing the estimand for this study, including eCRF data collection and methods for imputation and estimation.
The authors declare that they have no competing interests.
The authors declare that a positive ethics committee vote has been obtained.