Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency

BACKGROUND: Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug A...

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Detalhes bibliográficos
Main Authors: Elsäßer, Amelie, Regnstrom, Jan, Vetter, Thorsten, Koenig, Franz, Hemmings, Robert James, Greco, Martina, Papaluca-Amati, Marisa, Posch, Martin
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2014
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4196072/
https://ncbi.nlm.nih.gov/pubmed/25278265
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1745-6215-15-383
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