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Activity Number: 557 - Data Monitoring Committees – the Multi-Disciplinary Approach to Drug Safety Assessment
Type: Topic Contributed
Date/Time: Wednesday, July 31, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #301720 Presentation
Title: Are Interactive Graphics in a DMC Ready for Prime-Time, for Better Safety Reviews?
Author(s): James Buchanan*
Companies: Covilance LLC
Keywords: Drug safety; Safety monitoring; Tools; Interactive graphics; Hepatotoxicity; Signal detection

DMCs review safety information via traditional tables and listings but these standard outputs can be challenging. The DIA-ASA Biopharm Safety Evaluation Working Group is developing a series of novel interactive safety graphic tools to enhance the ability to identify and evaluate safety signals. Each will be made available as an open-source, non-proprietary application. The first tool to be released is designed to explore cases of potential drug-induced hepatotoxicity based on the eDISH plot developed by FDA. Building upon the existing static eDISH plot, the tool allows the user to dynamically adjust laboratory thresholds, modify the time dimension for the occurrence of peak ALT/AST and bilirubin values, account for the extent of alkaline phosphatase elevation, with filters for treatment, gender, race and age. Cases that appear in the potential Hy’s Law, Temple’s corollary and hyperbilirubinemia quadrants can be individually explored in further detail. The tool is accompanied by a proposed workflow to guide the analytical steps supported by references to the medical literature. This will allow DMC members to more easily identify safety signals and perform exploratory analyses.

Authors who are presenting talks have a * after their name.

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