Webinar 4: Overall Safety Assessment – Interactive Safety Graphics for Regulatory Decision-Making |
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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:
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 |
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Greg Ball, ASAP Process ConsultingGreg Ball served in the Navy and taught High School maths and physics before earning his master’s in statistics from Purdue and his PhD in Biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). With Mary Nilsson, Greg co-leads the PHUSE Safety Analytics Working Group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement. | |
Jeremy Wildfire, GileadJeremy 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, VeramedSteve 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/CDERMat 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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