Announcements

  • New Webinar: Deep Mining Signal Detectors: 07 Nov 2022 10am-11:30am ET

    The Statistics and Data Science Community are pleased to announce that registration is open for the Deep Mining Signal Detectors webinar being held on 07 Nov 2022, 10:00am - 11:30am ET. Registration is FREE and can be completed using the web address below

    Registration: https://diaglobal.zoom.us/webinar/register/WN_gl8XJLC8T4O_28swa4W-5Q

    Abstract

    The volume of laboratory data, even in a relatively small trial, can be daunting to review with sufficient depth of detail to identify safety signals. The challenge can be even greater when multiple laboratory abnormalities occur together to constitute a clinical syndrome or complex pathology which can evade detection when only individual lab abnormalities are sought. Interactive, open-source tools, such as being developed by the Interactive Safety Graphics taskforce of the DIA-ASA Biopharm Working Group, can offer a simple solution. This presentation will cover the variety of safety data visualization tools offered, including those that can detect study subjects with multiple lab abnormalities of interest, such as the Safety Outlier Explorer and the Hepatic Explorer. This year the taskforce seeks to offer several new tools, including a Renal Explorer to identify instances of acute kidney injury and a QT Explorer to detect occurrences of QT prolongation.

    • Presentation
    • Jeremy Wildfire (Gilead)
    • Jim Buchanan (Covilance)
    • Reaction
    • Paul (Skip) Hayashi (FDA)
    • Discussion
    • Moderator: Greg Ball (Novavax)
    • Jeremy Wildfire (Gilead)
    • Jim Buchanan (Covilance)
    • Paul (Skip) Hayashi (FDA)

    We hope you can join us for this interesting session.

    Registration: https://diaglobal.zoom.us/webinar/register/WN_gl8XJLC8T4O_28swa4W-5Q