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What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials?
BACKGROUND: Published in 2019, a new addendum to the ICH E9 guideline presents the estimand framework as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical analyses, and interpretation of results. The use of the estimand framework for desc...
Autores principales: | Lawrance, Rachael, Degtyarev, Evgeny, Griffiths, Philip, Trask, Peter, Lau, Helen, D’Alessio, Denise, Griebsch, Ingolf, Wallenstein, Gudrun, Cocks, Kim, Rufibach, Kaspar |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445213/ https://www.ncbi.nlm.nih.gov/pubmed/32833083 http://dx.doi.org/10.1186/s41687-020-00218-5 |
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