Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program

Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long‐term POC studies (≥48 weeks) add cost and time to the “Go/No Go” decision process. However, it is po...

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Detalles Bibliográficos
Autores principales: Williams, RN, Filozof, C, Goldstein, BJ, Cusi, K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Perspectives
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367378/
https://www.ncbi.nlm.nih.gov/pubmed/28032901
http://dx.doi.org/10.1002/cpt.560
Descripción
Sumario:Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long‐term POC studies (≥48 weeks) add cost and time to the “Go/No Go” decision process. However, it is possible to conduct short‐term noninvasive POC studies utilizing biomarkers and magnetic resonance imaging. Here, we discuss the use of shorter noninvasive POC studies relative to biopsy‐driven studies for drug development in NASH.

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