Safety Analytics – Project Volunteer Board

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

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

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

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)

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