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
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author Williams, RN
Filozof, C
Goldstein, BJ
Cusi, K
author_facet Williams, RN
Filozof, C
Goldstein, BJ
Cusi, K
author_sort Williams, RN
collection PubMed
description 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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spelling pubmed-53673782017-03-28 Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program Williams, RN Filozof, C Goldstein, BJ Cusi, K Clin Pharmacol Ther Perspectives 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. John Wiley and Sons Inc. 2016-12-29 2017-04 /pmc/articles/PMC5367378/ /pubmed/28032901 http://dx.doi.org/10.1002/cpt.560 Text en © 2016 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Perspectives
Williams, RN
Filozof, C
Goldstein, BJ
Cusi, K
Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
title Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
title_full Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
title_fullStr Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
title_full_unstemmed Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
title_short Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
title_sort structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program
topic Perspectives
url 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
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