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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Detalles Bibliográficos
Autores principales: Pateras, Konstantinos, Nikolakopoulos, Stavros, Roes, Kit C. B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Research Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252448/
https://www.ncbi.nlm.nih.gov/pubmed/33813759
http://dx.doi.org/10.1002/sim.8952

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252448/
https://www.ncbi.nlm.nih.gov/pubmed/33813759
http://dx.doi.org/10.1002/sim.8952

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