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    Estimands in Safety Analytics

      Estimands in Safety Analytics

      Oct 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 Coordinator nicky@phuse.global 
      Objectives and DeliverablesTimetables

      Series of Training Modules

      TBC
      White Paper TBC

      CURRENT STATUS (Updated Quarterly) 

      • Continued progress on self-study materials by all four sub-teams, addressing the four key topic areas identified​
      • Draft slide decks available for three of the sub teams; content staging nearly complete for the fourth​
      • Poster presentation of the team's work at the 2025 EFSPI regulatory statistics workshop (September)
      • Self-study materials in peri-final form for all four sub-teams​
      • Begin video and webinar preparations


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