Empirical evaluation of the implementation of the EMA guideline on missing data in confirmatory clinical trials: Specification of mixed models for longitudinal data in study protocols

In confirmatory clinical trials, the prespecification of the primary analysis model is a universally accepted scientific principle to allow strict control of the type I error. Consequently, both the ICH E9 guideline and the European Medicines Agency (EMA) guideline on missing data in confirmatory cl...

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Detalles Bibliográficos
Autores principales: Häckl, Sebastian, Koch, Armin, Lasch, Florian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Main Papers
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899721/
https://www.ncbi.nlm.nih.gov/pubmed/31267673
http://dx.doi.org/10.1002/pst.1964

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899721/
https://www.ncbi.nlm.nih.gov/pubmed/31267673
http://dx.doi.org/10.1002/pst.1964

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