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Catch up Here!
This Webinar took place 4 October. Catch up by viewing the recording or reading the slides.

Webinar 4: Overall Safety Assessment – Interactive Safety Graphics for Regulatory Decision-Making

4 October 15:00–16:30 (BST) 10:00–11:30 (EDT)

Abstract: 

Clinical trials would benefit from a standardised set of non-proprietary tools for interactively evaluating clinical safety data. Unfortunately, analysis of clinical trials remains highly variable across organisations, utilising a mix of commercial analytics tools and custom statistical programming that remains focused on the creation of static tables, listings and figures. This lack of a shared approach is inefficient, expensive and limits innovation. However, new opportunities utilising open-source software and large community collaborations are emerging.

This webinar will examine the use of graphical approaches to evaluate clinical trial safety data with an emphasis on new developments in interactive graphical approaches. In particular: 

  • Jeremy Wildfire will present on his experience developing the safetyGraphics R package, a collaboration including members from over 15 organisations, including pharmaceutical companies, academia and the FDA. 
  • Steve Mallett will summarise some of the unique challenges in safety data analysis, highlight how standards and tools for visualising safety data have evolved in recent years, and discuss future trends with a focus on collaboration across industry, regulators and academia.
  • Mat Soukup will discuss past efforts to move from tabular and line listings of safety data to static graphic representations of safety data – efforts made possible through a collaboration of academia, industry and regulatory parties.

Finally, the panel will discuss next steps for making open-source tools a standard part of the clinical trial workflow. 

This webinar is the fourth of five webinars related to interdisciplinary safety evaluation, with an overall goal to improve the content and implementation of safety analysis for medical research, leading to better data interpretations, better decision-making, and increased efficiency in the clinical drug development and review processes.

Presenter Bio 

Jeremy Wildfire, Gilead 

Jeremy Wildfire is a data scientist at Gilead and is focused on creating modern tools that improve the analysis pipeline for clinical trials. Jeremy has served as the technical lead for the Interactive Safety Graphics (ISG) sub-team of the ASA Biopharm-DIA Safety Working Group since 2018. The working group is an interdisciplinary effort that seeks to provide a clinical safety workflow for monitoring during clinical development in an open-source model. The ISG team created a workflow to monitor hepatoxicity using the safetyGraphics R package and a well-documented based on the safety clinician’s monitoring practice. The working group has recently expanded its focus to include additional safety domains such as adverse events, QT and nephrotoxicity.

Steve Mallett, Veramed

Steve Mallett has over 25 years’ experience working in the pharmaceutical industry as a statistical programmer and statistician. He has supported many medicine development projects, from early phase through to medical affairs. Steve recently joined Veramed as a senior manager and is also an active member of the PSI special interest group for data visualisation. 

Mat Soukup, FDA/CDER

Mat Soukup received his PhD in Biostatistics from the University of Virginia in 2004 and joined the FDA/CDER as a statistical reviewer shortly thereafter. In 2010, he joined the Division of Biometrics VII as Team Lead and now serves as Deputy Division Director. In these roles, Mat has contributed and promoted appropriate statistical methodologies for the quantitative assessment of safety across a broad spectrum of topics such as meta-analysis, causal inference, signal detection, statistical graphics, and design of safety outcome trials.

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