Randomized controlled trial data for successful new drug application for rare diseases in the United States

BACKGROUND: Randomized controlled trial (RCT) data have important implications in drug development. However, the feasibility and cost of conducting RCTs lower the motivation for drug development, especially for rare diseases. We investigated the potential factors associated with the need for RCTs in...

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Detalles Bibliográficos
Autores principales: Kubota, Yosuke, Narukawa, Mamoru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10114466/
https://www.ncbi.nlm.nih.gov/pubmed/37076897
http://dx.doi.org/10.1186/s13023-023-02702-9

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10114466/
https://www.ncbi.nlm.nih.gov/pubmed/37076897
http://dx.doi.org/10.1186/s13023-023-02702-9

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