Addressing Data Challenges in Drug Induced Liver Injury

Identification of drug-induced liver injury (DILI) is hindered by the lack of a structured, standardized approach to its identification and evaluation. This leads to inefficiencies for both sponsors and regulators. Guidance related to data submission for DILI evaluation can improve the efficiency of regulatory review, for example, by reducing the number of information requests sent by the FDA to industry sponsors. Ultimately, improved strategies for DILI data gathering and submission will also improve the accuracy of DILI risk assessment. This webinar will delve into a detailed discussion of the challenges associated with reviewing clinical data and propose potential strategies to enhance data quality and improve efficiency. For instance, the ASA Safety Working Group's ASAP Taskforce has suggested a template for ongoing aggregated safety assessment planning. This template includes sections on identifying safety topics of interest, determining the necessary safety data collection to address those topics, outlining methods for data collection, and strategies for analysis. Sponsors can utilize this template as a guide to identify safety topics and develop strategies and plans for safety data collection and analysis. The Interactive Safety Graphics (ISG) Taskforce developed an interactive eDISH tool and an interactive patient profile app to facilitate sponsors to enhance the ability of identifying DILI cases within the framework of ASAP. By aligning with the suggested template and deploying the interactive tools, employing best practices for proactive planning, data collection and analysis, sponsors can contribute to more effective safety assessment within the clinical research and regulatory context.