Assessment of drug-induced liver injury from clinical trial data
Michael K. Merz · Clinical Therapeutics · 2013
Proper analysis of liver safety data is multivariate by nature and has to take into account time dependency of observations. Current standard tools for liver safety assessment are summary tables, individual data listings, narratives, and static graphs. An efficient complementary approach is use of interactive graphics, ideally in a team-based setting. A systematic workflow including predefined graph templates helps to ensure completeness of evaluations, supports hypothesis generation and testing, and facilitates identification of the most suitable graphics for publishing and regulatory reporting. The use of interactive graphics instead of focusing on static graphs enables a project team to jointly assess biomarker data, helps to thoroughly query the data from different perspectives, and fosters team ownership of both analysis and conclusions. This talk presents a systematic workflow for liver safety assessment using a series of interactive graph templates.