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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Salvato in:
Dettagli Bibliografici
Pubblicato in:Trials
Autori principali: Collignon, Olivier, Koenig, Franz, Koch, Armin, Hemmings, Robert James, Pétavy, Frank, Saint-Raymond, Agnès, Papaluca-Amati, Marisa, Posch, Martin
Natura: Artigo
Lingua:Inglês
Pubblicazione: BioMed Central 2018
Soggetti:
Research
Accesso online: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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