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Reporting of master protocols towards a standardized approach: A systematic review

BACKGROUND: In September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. Master protocols refer to a single overarching protocol developed to evaluate multiple hypotheses and may be further categorized as basket, umbrella, and...

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Detalhes bibliográficos
Publicado no:Contemp Clin Trials Commun
Main Authors: Siden, Ellie G., Park, Jay JH., Zoratti, Michael J., Dron, Louis, Harari, Ofir, Thorlund, Kristian, Mills, Edward J.
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier 2019
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6616543/
https://ncbi.nlm.nih.gov/pubmed/31334382
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.conctc.2019.100406
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