title: Strategies and endpoints of antifibrotic drug trials: Summary and recommendations from the AASLD Emerging Trends Conference, Chicago, June 2014.
abstract: 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.
authors: Department of Gastroenterology and Hepatology, UC Davis Medical Center, Sacramento, CA and VA Northern California Healthcare System, Mather CA.
authors: Natalie J
authors: NJ
authors: Torok
authors: Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, and Research Service, Central Arkansas VA Healthcare System, Little Rock, AR.
authors: Jonathan A
authors: JA
authors: Dranoff
authors: Institute of Translational Immunology and Research Center for Immunotherapy, University Medical Center, Mainz, Germany.|Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
authors: Detlef
authors: D
authors: Schuppan
authors: Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.
authors: Scott L
authors: SL
authors: Friedman
mesh_terms: D002641:Chicago; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D015195:Drug Design; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D017410:Practice Guidelines as Topic; D055553:Prescription Drugs / Q000494:pharmacology*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs
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