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Safety Analytics – Project Volunteer Board

Safety Analytics – Project Volunteer Board

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Welcome!

Welcome!

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

Estimands in Safety Analytics - Starting Q1 2025

Estimands in Safety Analytics - Starting Q1 2025

Project Scope:

  • Develop a user-friendly, one-stop education portal on the topic of safety estimands.

  • Encompass and reference the learnings and recommendations of other external groups working on safety estimands – work in a complementary and comprehensive fashion, and ensure information is presented in a digestible, fit-for-application manner.

  • Develop an education series with the goals of (1) substantially increasing the comfort level of safety scientists when articulating appropriate safety estimands (2) increasing their use in practice and (3) increasing the breadth of estimators routinely used in safety analytics.

Regular Project Meeting Day/Time:

  • Monthly: Thursday 13:00-14:00 BST

  • There are separate Sub-Team meetings

Key Skills:

  • Statistical background

  • Applied clinical background

  • Ability to work effectively in a (potentially large) team environment

  • Drive for collaboration in defining project sub-components

  • Expectation to assume responsibility for “hands-on” deliverables and capacity for timely delivery

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)

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 publicize project deliverables