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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Detalhes bibliográficos
Publicado no:Trials
Main Authors: Collignon, Olivier, Koenig, Franz, Koch, Armin, Hemmings, Robert James, Pétavy, Frank, Saint-Raymond, Agnès, Papaluca-Amati, Marisa, Posch, Martin
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2018
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6245528/
https://ncbi.nlm.nih.gov/pubmed/30454061
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13063-018-3012-x
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