Estimands in Safety Analytics

Estimands in Safety Analytics

Problem Statement

Problem Statement

  • Develop a user-friendly, one-stop education portal on the topic of safety estimands.

  • Encompass and reference the learnings and recommendations of external groups working on safety estimands – work in a complementary and comprehensive fashion, and present information 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.

Project Scope

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.

Project Leads

Emails

Project Leads

Emails

Andreas Sashegyi, Lilly

aisasheg@lilly.com  

Michael Colopy, Polaris Data Labs

mike@polarisdatalabs.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global 

Objectives and Deliverables

Timetables

Objectives and Deliverables

Timetables

Series of Training Modules

TBC

White Paper

TBC

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