Safety Scientific Working Group

Summary

The Interactive Safety Graphics group is a taskforce within the broader American Statistical Association Biopharmaceutical Safety Working Group that is developing graphical tools for the drug safety community. The group is comprised of volunteers from the pharmaceutical industry, regulatory agencies and academia to develop creative and innovative interactive graphical tools following the open source paradigm. A variety of tools for AE and laboratory analyses have already been released as part of the Safety Explorer Suite and the Hepatic Explorer. The ISG group has continued to innovate and three new interactive visualization tools will be the subject of today’s webinar.

The interactive AE volcano plot allows users to view the overall distribution of AEs in a clinical trial using standard (e.g. MedDRA preferred term) or custom (e.g. Gender) categories using a volcano plot similar to proposal by Zink et al. (2013). This tool provides a stand-alone shiny application and flexible shiny modules allowing this tool to be used as a part of more robust safety monitoring framework like the Shiny app from the ‘safetyGraphics’ R package.

The Renal Explorer empowers clinical trial monitoring of patient kidney function efficiently by graphically displaying two different systems for classifying renal injury: KDIGO criteria and Delta Creatinine. Individual patients can be selected from aggregate displays to further drill down into patient profiles. These profiles display patient lab results over time, focusing on important kidney function and patient health markers like eGFR, serum creatinine, Cystatin C, and urine Albumin/Creatinine. The renal explorer tool can be used as a stand-alone shiny application and is slated to integrate with the safetyGraphics R package framework in 2024.

The {safetyProfile} package contains a shiny app that allows users to view subject-level profile reports for patients participating in clinical trials. The visualizations included in the package present a patient-centric summary of parameter changes over the trial period, including laboratory results, concomitant medications, adverse events along with participant demographics data. The {safetyProfile} can be used as a stand-alone shiny application and at the same time its flexible shiny modules allow the tool to be used as a part of the {safetyGraphics} R package (robust safety monitoring framework).

Agenda

Session 1 (May 22, 2024): Benefit–Risk Assessment Processes, Visualizations and more — AstraZeneca & UCB

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Session 2 (June 20, 2024): Benefit–Risk Assessment Processes, Visualizations and more — Bayer & GSK

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Abstract

Recently, CIOMS WG XII Benefit-Risk report was released, outlining the benefit-risk (BR) landscape and promoting the use of a structured BR framework (SBRF) from the beginning and continuously updated and applied throughout the product lifecycle, including key decision-making steps. The report also mentioned the visualization of benefit-risk assessment (BRA) and its importance in the BR process. Members from CIOMS WG XII will provide an overview of this document. Members from BRAP and BRATS will discuss the WG’s deliverables and progress (such as BRAP’s template that is under development), and BRATS efforts and considerations for an R-Shiny based interactive tool. The discussion will be focused on:

• How BRAP and BRATS efforts align with the CIOMS XII’s work
• Potential areas for BRAP and BRATS to consider adjustments/improvements based on CIOMS XII and FDA guidance documents

Agenda