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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...
Autores principales: | Collignon, Olivier, Koenig, Franz, Koch, Armin, Hemmings, Robert James, Pétavy, Frank, Saint-Raymond, Agnès, Papaluca-Amati, Marisa, Posch, Martin |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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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 |
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