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Combined assessment of early and late‐phase outcomes in orphan drug development

In drug development programs, proof‐of‐concept Phase II clinical trials typically have a biomarker as a primary outcome, or an outcome that can be observed with relatively short follow‐up. Subsequently, the Phase III clinical trials aim to demonstrate the treatment effect based on a clinical outcome...

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Detalhes bibliográficos
Publicado no:Stat Med
Main Authors: Pateras, Konstantinos, Nikolakopoulos, Stavros, Roes, Kit C. B.
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2021
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8252448/
https://ncbi.nlm.nih.gov/pubmed/33813759
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/sim.8952
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