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2015 ; 62
(2
): 627-34
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gab.com Text
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English Wikipedia
Strategies and endpoints of antifibrotic drug trials: Summary and recommendations
from the AASLD Emerging Trends Conference, Chicago, June 2014
#MMPMID25626988
Torok NJ
; Dranoff JA
; Schuppan D
; Friedman SL
Hepatology
2015[Aug]; 62
(2
): 627-34
PMID25626988
show ga
There is an urgent need to develop antifibrotic therapies for chronic liver
disease, and clarify which endpoints in antifibrotic trials will be acceptable to
regulatory agencies. The American Association for the Study of Liver Diseases
sponsored an endpoints conference to help accelerate the efficient testing of
antifibrotic agents and develop recommendations on clinical trial design for
liver fibrosis. In this review, we summarize the salient and novel elements of
this conference and provide directions for future clinical trial design. The
article follows the structure of the conference and is organized into five areas:
(1) antifibrotic trial design; (2) preclinical proof-of-concept studies; (3)
pharmacological targets, including rationale and lessons to learn; (4) rational
drug design and development; and (5) consensus and recommendations on design of
clinical trials in liver fibrosis. Expert overviews and collaborative discussions
helped to summarize the key unmet needs and directions for the future, including:
(1) greater clarification of at-risk populations and study groups; (2)
standardization of all elements of drug discovery and testing; (3)
standardization of clinical trial approaches; (4) accelerated development of
improved noninvasive markers; and (5) need for exploration of potential
off-target toxicities of future antifibrotic drugs.
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