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Estimands in Safety Analytics

Estimands in Safety Analytics

Owned by Nicola Newton
Last updated: Apr 01, 2025

Problem Statement

The value of well-defined safety estimands is not generally appreciated and has not been communicated well to safety scientists. 

  • Safety analyses are often ambiguous and, in some cases, carry the risk of being misinterpreted.
  • A better understanding and consequently a more consistent application of a robust estimand framework in the analysis of safety data would eliminate this ambiguity and drive clarity on both the specific question an analysis addresses, as well as the answer to that question.

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 LeadsEmails
Michael Colopy, Polaris Data Labs

mike@polarisdatalabs.com

Andreas Sashegyi, Lillyaisasheg@lilly.com  
Nicola Newton, PHUSE Project Assistantnicky@phuse.global 
Objectives and DeliverablesTimetables

Series of Training Modules

TBC
White Paper TBC

CURRENT STATUS Q4 2024

  • Call for members; project team formed with 17 members spanning 8 organisations.
  • Kick -off meeting held 18 Febuary.
  • Scope refinement in process – subtopics to be addressed with educative modules will be agreed to by the beginning of May; team members to be assigned to smaller working groups to develop content


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