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    Safety Analytics Education

      Safety Analytics Education

      Oct 01, 2025

      Project Scope
      Development and delivery of education relevant to clinical trial safety analyses, with a focus on Phase 2-3.
      Problem Statement 

      Planning and interpreting clinical trial safety analyses demands scientific expertise that is often missing in educational curricula. The Safety Analytics field is dynamic and evolving, requiring continual learning. All the roles (for example, medical, statistics, writers) that collaborate on ongoing safety reviews, clinical study reports and integrated submission documents can improve their planning, content, execution, and communication of clinical trial safety analyses.

      Problem Impact

      Improving Safety Analytics Education will lead to better content, implementation, and understanding of clinical trial safety analyses. Additionally, when stakeholders are educated, less time is needed for aligning on analysis plans and data interpretations.

      Members of the Safety Analytics Education project team have been active in delivering and promoting educational content for a while:

      • Leading Safety Analytics workshops at the PHUSE CSS
      • Presenting at the Duke Margolis-FDA workshop on advancing premarket safety analytics
      • Partnering with the PHUSE Education team to create and maintain a Safety Analytics Education website
      • Hosting a webinar series on Interdisciplinary Safety Evaluation for Decision-Making

      The Education project team will provide a dedicated channel for future efforts and enhance the standing of PHUSE in the safety analytics space.

      Project Leads

      Emails

      Christopher Smith, FDA

      Christopher.Smith2@fda.hhs.gov

      William Palo, (Volunteer)

      william.palo@phuse.global

      Nicola Newton, PHUSE Project Coordinator

      nicky@phuse.global

      CURRENT STATUS (Updated Quarterly) 

      • Finalised scope for hepatotoxicity webinar and weekly LinkedIn posts
      • Present Hepatotoxicity webinar; initiate weekly LinkedIn posts to highlight safety library

      Objectives & Deliverables 

      Timelines 

      Enhance the existing Safety Analytics Education website

      Ongoing 

      Deliver webinars on safety content

      Ongoing 
      Education Resources:
      Education Page
      Reimagining a Safety Submission – Vision of Interactive Safety Reviews

      Aggregate Safety Assessment Planning-Community Forum

      Safety Analytics Workshop 2020

      Safety Analytics Workshop 2019

      Webinar series on Interdisciplinary Safety Evaluation for Decision-Making


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