Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments

BACKGROUND: Clinical trials for treatments indicated for orphan diseases may be limited due to the low prevalence of such diseases; this can result in implications for both regulatory and health economic perspectives. This study assessed the pivotal clinical evidence packages submitted to support ap...

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Veröffentlicht in:Orphanet J Rare Dis
Hauptverfasser: Winstone, Julie, Chadda, Shkun, Ralston, Stephen, Sajosi, Peter
Format: Artigo
Sprache:Inglês
Veröffentlicht: BioMed Central 2015
Schlagworte:
Research
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4625856/
https://ncbi.nlm.nih.gov/pubmed/26511061
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-015-0349-z
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