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Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example

Regulatory guidelines describe the use of estimands in designing and conducting clinical trials. Estimands ensure alignment of the objectives with the design, conduct and analysis of a trial. An estimand is defined by four inter‐related attributes: the population of interest, the variable (endpoint)...

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Detalles Bibliográficos
Autores principales: Aroda, Vanita R., Saugstrup, Trine, Buse, John B., Donsmark, Morten, Zacho, Jeppe, Davies, Melanie J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771751/
https://www.ncbi.nlm.nih.gov/pubmed/31168921
http://dx.doi.org/10.1111/dom.13804