The Hepatotox package was developed to support clinical trials investigating drug-induced liver injury (DILI), also referred to as hepatotoxicity. Because DILI remains a leading cause of late-stage drug development failures and post-marketing withdrawals, standardized tools for analyzing liver safety signals are essential. The Hepatotox package addresses this need by providing a consistent set of analyses and visual displays that help researchers detect, interpret, and communicate patterns of liver enzyme changes in response to investigational drugs.
Built using R programming and Shiny applications, the package combines robust statistical workflows with interactive visualizations. These tools allow trial teams to explore enzyme elevations, bilirubin trends, and combinations of biomarkers that can indicate emerging safety concerns. Beyond static tables, the package emphasizes intuitive graphical displays—such as scatter plots and forest plots—that highlight clinically meaningful findings that might otherwise be overlooked in raw listings.
By standardizing how liver safety data are summarized and displayed, the Hepatotox package serves both scientific and regulatory audiences. Clinical researchers gain an efficient way to interpret complex datasets, while regulatory reviewers benefit from transparent, reproducible analyses aligned with current guidance on DILI evaluation. As such, the package represents a practical step forward in harmonizing liver safety assessments across trials, ultimately supporting safer drug development and clearer decision-making.