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Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency

BACKGROUND: In recent years, experience on the application of adaptive designs in confirmatory clinical trials has accumulated. Although planning such trials comes at the cost of additional operational complexity, adaptive designs offer the benefit of flexibility to update trial design and objective...

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Detalles Bibliográficos
Autores principales: Collignon, Olivier, Koenig, Franz, Koch, Armin, Hemmings, Robert James, Pétavy, Frank, Saint-Raymond, Agnès, Papaluca-Amati, Marisa, Posch, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6245528/
https://www.ncbi.nlm.nih.gov/pubmed/30454061
http://dx.doi.org/10.1186/s13063-018-3012-x