Safety Analytics – Project Volunteer Board

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

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.

Current Status:

• Project Approved

• Calling For Volunteers

Regular Project Meeting Day/Time:

• Kick Off Meeting: 18 February 14:00-15:00 GMT

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

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/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.

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.

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

• Webinars (3-4 per year)

• Continued enhancements to the safety library (link)

Current Status:

• Developing webinar ideas for 2025 

• Enhancing safety library format

Regular Project Meeting Day/Time:

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

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