Endpoints and patient stratification in clinical trials for alcoholic hepatitis

In some areas of medicine the clinical development pathway through phase II and III clinical trials has been well mapped out and refined through extensive experience. In contrast, a number of key questions remain unanswered in the development of novel therapeutics for alcoholic hepatitis. The use of mortality as an endpoint in phase II clinical trials will potentially restrict the appeal of this therapeutic area for pharmaceutical companies, as the number of patients required for adequately powered clinical trials becomes impractical.
Source: Journal of Hepatology - Category: Gastroenterology Authors: Tags: Review Source Type: research