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Using phase II data for the analysis of phase III studies: An application in rare diseases

BACKGROUND: Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make bett...

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Detalhes bibliográficos
Publicado no:Clin Trials
Main Authors: Wandel, Simon, Neuenschwander, Beat, Röver, Christian, Friede, Tim
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2017
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5833035/
https://ncbi.nlm.nih.gov/pubmed/28387537
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1740774517699409
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