Journal
JOURNAL OF DIGESTIVE DISEASES
Volume 21, Issue 1, Pages 3-11Publisher
WILEY
DOI: 10.1111/1751-2980.12830
Keywords
clinical trial; drug design; nonalcoholic steatohepatitis
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Funding
- Major Project of National Thirteenth Five Plan [2017ZX09304016]
- Major Project of National Twelfth Five Plan [2012ZX09303-001]
- National Natural Science Foundation of China [81670524]
- Shanghai Shenkang Hospital Development Center [16CR2009A]
- Clinical Research Center, School of Medicine, Shanghai Jiao Tong University [DLY201607]
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The development of new drugs for nonalcoholic steatohepatitis (NASH) is a current focus of research in the management of liver disease. Here we provided an overview of NASH drug pipelines and the challenges faced in conducting phases II and III clinical trials. These challenges include the selection and definition of research populations, rational selection of study end-points, choice of noninvasive diagnostic indicators, accounting for confounding factors and safety assessments. Furthermore, we discussed how to establish guidelines for study design and end-points in complex clinical trials of anti-NASH drugs.
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