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.

Current Status:

• Project Approved

• Calling For Volunteers

Regular Project Meeting Day/Time:

• Kick Off Meeting: 25 February 16:00-17:00 GMT

Key Skills: (currently being reviewed by WG Leads)

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.

Current Status:

• Finalise Stage 1 white paper following public review.

• Get Stage 2 white paper ready for public review.

Regular Project Meeting Day/Time:

• Leads to confirm

Key Skills: (currently being reviewed by WG Leads)

• Medical background for Stage 2

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.

Current Status:

• Update to previous PHUSE deliverables, with considerations of interactivity.

Regular Project Meeting Day/Time:

• Bi-Weekly: Thursdays 15:00-16:00 GMT

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.

Current Status:

• Updates to safety library.

Regular Project Meeting Day/Time:

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

Key Skills: (currently being reviewed by WG Leads)