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External control arms for rare diseases: building a body of supporting evidence

Comparator arms in randomized clinical trials may be impractical and/or unethical to assemble in rare diseases. In the absence of comparator arms, evidence generated from external control studies has been used to support successful regulatory submissions and health technology assessments (HTA). Howe...

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Detalles Bibliográficos
Autores principales: Khachatryan, Artak, Read, Stephanie H, Madison, Terri
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10673956/
https://www.ncbi.nlm.nih.gov/pubmed/37095406
http://dx.doi.org/10.1007/s10928-023-09858-8

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