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    Safety Analytics – Project Volunteer Board
    Updated Oct 06

      Safety Analytics – Project Volunteer Board

      image-20250109-111808.png

      Welcome!

      Welcome!

      Interested in joining one of the Safety Analytics Working Group Projects? The projects below welcome new volunteers.

      Process for Aggregate Assessment of Clinical Trial AE Data - Starting Q1 2025

      Process for Aggregate Assessment of Clinical Trial AE Data - Starting Q1 2025

      Project Scope:

      • Define the different challenges and processes needed for aggregate AE assessment for development programmes with medium duration/low subject number, short duration/medium subject number, and long duration/high subject number.

      • Delineate efficient standardised processes for each stage and identify where new technologies can strengthen the reliability of assessment.

      • Delineate potential pitfalls when processes appropriate to one stage are applied to a different stage.

      Regular Project Meeting Day/Time:

      • Monthly: Thursday 16:00-17:00 BST

      • There are separate Sub-Team meetings

      Key Skills/Expertise:

      • Clinical trial development

      • Pharmacovigilance

      • Data analysis

      Analyses & Displays for Hepatotoxicity

      Analyses & Displays for Hepatotoxicity

      Project Scope:

      This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.

      Regular Project Meeting Day/Time:

      • Leads to confirm

      Key Skills:

      • Medical background for Stage 2

      • MDs who are experts in DILI assessment

      Interactive Analyses and Displays for Laboratory Data – Started Q3 2023

      Interactive Analyses and Displays for Laboratory Data – Started Q3 2023

      Project Scope:

      Interactive Analyses and Displays of laboratory data, applicable to Phase 2-3 clinical trials and integrated submission documents. Creating interactive analyses and displays would allow more options for the user without adding substantial volume and would provide a more user-friendly method for reviewing laboratory data. Multiple groups are involved in creating interactive displays or tools for clinical trial data, and having a deliverable outlining the desired features, with associated education on interpreting the analyses/displays, would help progress the overall efforts.

      Regular Project Meeting Day/Time:

      • Bi-Weekly: Thursday 17:00-18:00 & 18:00-19:00 BST

      Key Skills: (currently being reviewed by WG Leads)

      • Data visualisation expertise

      • Statistical programming proficiency

       

      Safety Analytics Education – Started Q1 2024

      Safety Analytics Education – Started Q1 2024

      Project Scope:

      • Development and delivery of education relevant to clinical trial safety analyses, with a focus on Phase 2-3.

      • This is an ongoing project that will deliver multiple outputs per year:

      • Webinars (3-4 per year)

      • Continued enhancements to the safety library (link)

      Regular Project Meeting Day/Time:

      • Bi-Weekly: Wednesday 15:00-16:00 BST

      Key Skills:

      • Gather ideas for project deliverables

      • Help coordinate and facilitate webinars

      • Develop and maintain content for safety library

      • Engage personal and professional networks to publicise project deliverables

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