Cargando…
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)...
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 |
Ejemplares similares
-
Estimands for factorial trials
por: Kahan, Brennan C., et al.
Publicado: (2022) -
Principles and recommendations for incorporating estimands into clinical study protocol templates
por: Lynggaard, Helle, et al.
Publicado: (2022) -
Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples Based on a Psychiatric Disorder
por: Polverejan, Elena, et al.
Publicado: (2023) -
Estimands: bringing clarity and focus to research questions in clinical trials
por: Clark, Timothy Peter, et al.
Publicado: (2022) -
Translating questions to estimands in randomized clinical trials with intercurrent events
por: Stensrud, Mats J., et al.
Publicado: (2022)