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Beyond “Intent‐to‐treat” and “Per protocol”: Improving assessment of treatment effects in clinical trials through the specification of an estimand

There is a key problem in randomised clinical trials as outcomes can be distorted due to informative post‐randomisation events. This is inadequately addressed by the use of traditional intention‐to‐treat or per protocol analysis sets and often either ignored or wrongly labelled as missing data. As a...

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Detalles Bibliográficos
Autores principales: Pétavy, Frank, Guizzaro, Lorenzo, Antunes dos Reis, Inês, Teerenstra, Steven, Roes, Kit C.B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319001/
https://www.ncbi.nlm.nih.gov/pubmed/31883123
http://dx.doi.org/10.1111/bcp.14195