Versions Compared

Version Old Version 5 New Version 6
Changes made by

Nicola Newton

Lucy Marks

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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.

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)/Expertise:

  • Clinical trial development

  • Pharmacovigilance

  • Data analysis

Analyses & Displays for Hepatotoxicity – Started Q

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

...