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

Abstract 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 o...

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Detalhes bibliográficos

Principais autores:	Olivier Collignon, Franz Koenig, Armin Koch, Robert James Hemmings, Frank Pétavy, Agnès Saint-Raymond, Marisa Papaluca-Amati, Martin Posch
Formato:	Artigo
Idioma:	Inglês
Publicado em:	BMC 2018-11-01
coleção:	Trials
Assuntos:	Clinical trials regulation Interim analysis Seamless phase II/III Sample size re-assessment Stopping for futility
Acesso em linha:	http://link.springer.com/article/10.1186/s13063-018-3012-x
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