Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic
Claudia Filozof, Shein‐Chung Chow, Lara Dimick‐Santos, Yeh‐Fong Chen, Richard N. Williams, Barry J. Goldstein, Arun Sanyal – 1 August 2017 – Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic strategies for patients with this disease. Unfortunately, its long and asymptomatic natural history, the uncertainties about disease progression, the fact that most patients are undiagnosed, and the requirement for sequential liver biopsies create substantial challenges for clinical development.