Graphical Approaches to Evaluate Liver Safety Data in Clinical Trials

• Activity Number: 372
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Melissa Schultz* and Scott Diegel
• Companies: University of Wisconsin and University of Wisconsin
• Keywords: clinical trial ; graphics ; liver safety

Abstract

Analysis of liver safety data in clinical trials is a key safety challenge for sponsors and regulatory authorities, and for interim reviews by a Data Monitoring Committee (DMC). Standard tables have a limited ability to address this need; the addition of graphical displays makes it easier for the reviewer to quickly absorb meaningful patterns in the data and discern possible safety signals, helping to improve the evaluation of potential liver concerns. The University of Wisconsin Statistical Data Analysis Center serves as an independent biostatistics group, reporting analyses of accumulating data from ongoing clinical trials, for review by independent DMCs. Our reports focus on graphical presentations to facilitate comparisons between treatments and over time, and to communicate a large amount of information in a short amount of time. Here we present various ways to use graphics to help address clinical liver safety concerns, such as the frequency and maximum levels of elevations of lab tests across treatment groups, possible correlation between changes in different tests, and patient profiles showing time course including lab results, treatment status, and related events.