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Early phase clinical trials extension to guidelines for the content of statistical analysis plans

This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stake...

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Detalles Bibliográficos
Autores principales: Homer, Victoria, Yap, Christina, Bond, Simon, Holmes, Jane, Stocken, Deborah, Walker, Katrina, Robinson, Emily J, Wheeler, Graham, Brown, Sarah, Hinsley, Samantha, Schipper, Matthew, Weir, Christopher J, Rantell, Khadija, Prior, Thomas, Yu, Ly-Mee, Kirkpatrick, John, Bedding, Alun, Gamble, Carrol, Gaunt, Piers
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8819597/
https://www.ncbi.nlm.nih.gov/pubmed/35131744
http://dx.doi.org/10.1136/bmj-2021-068177