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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BACKGROUND: In September 2018 the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry.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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6616543/ https://www.ncbi.nlm.nih.gov/pubmed/31334382 http://dx.doi.org/10.1016/j.conctc.2019.100406 |