Content Comparison

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 14Monthly: Thursday 13:00-1514:00 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 GMTTBC

Key Skills/Expertise:

• Clinical trial development

• Pharmacovigilance

• Data analysis