Considerations on the Quality of Clinical Trials on Non-alcoholic Fatty Liver Disease Pages 1-5

Li Zhang1,2 and Guang Ji1,2,3

1Institute of Digestive Disease, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, China; 2China-Canada Center of Research for Digestive Diseases (ccCRDD), China; 3E-Institute of Shanghai Municipal Education Commission, Shanghai University of Traditional Chinese Medicine, China

http://dx.doi.org/10.12970/2308-6483.2016.04.01.1

Abstract: Non-alcoholic fatty liver disease (NAFLD) become the focus of health concern due to the liver injury it caused and a series of metabolic disorders it brought. Since therapeutic methods are limited, potential agents or compounds that target the diseases are urgently needed, thus high level clinical trials with standardized design are the essential step for the application of new drugs on NAFLD. Although quite a number of clinical reports on NAFLD have released, questions are still there, some of the key issues, such as evaluative criteria, behavior intervention control and efficacy parameters selection, failed to get common consensus worldwide. In addition, some of the important definitions on NAFLD diagnosis were confusing. Aiming at the aforementioned questions, we tried to give comments and suggestions, expecting to contribute to the quality improvement of clinical NAFLD trials.

Keywords: Non-alcoholic fatty liver disease, trials, design, evaluation. Read more