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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Bibliographic Details
Main Authors: Olivier Collignon, Franz Koenig, Armin Koch, Robert James Hemmings, Frank Pétavy, Agnès Saint-Raymond, Marisa Papaluca-Amati, Martin Posch
Format: Article
Language:English
Published: BMC 2018-11-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-018-3012-x