Advancing Safety Analyses with AEGiS Working Group Updates
"Discover the latest updates from the AEGiS Working Group, focused on improving safety assessments through innovative AE groupings. Learn about their objectives, activities to date, and future plans for enhancing pre-market safety analytics." (299 characters)
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Presentation Transcript
AE Groupings in Safety (AEGiS) Working Group Update PHUSE Community Forum 16 Feb 2023 Peg Fletcher and Mac Gordon
Who We Are Almost 30 clinical and analytical experts from the FDA, industry (spanning small, medium, large pharma) and consulting firms Monthly working group meetings to advance the AEGiS objectives
AEGiS Objectives 1. Define best practices for ensuring that similar types of adverse events are considered together for purposes of safety analyses. 2. Develop points to consider and recommendations on the process and implementation of AE groupings. 3. Recommend efficient standardized processes that can leverage new technologies. Note: Developing AE groupings is not in the AEGiS remit.
Activities to date Activities to Date Formation of the AEGiS working group mid-2022 Developed AEGiS white paper goals Discuss the importance of improving safety assessment utilizing AE groupings with descriptions of types available (e.g. MedDRA SMQs and MLGs, FDA FMQs, custom) Provide recommendations concerning types of groupings and ways to implement to support various objectives (e.g. signal detection, safety topics of interest, planning documentation, submissions) Finalized Table of Contents of the white paper Identified authors of white paper sections with draft outlines complete
MedDRA (SMQs) and FDA (FMQs) Groupings MedDRA Standardized MedDRA Queries (SMQs): www.meddra.org Standardized medical terminology used broadly across industry (~110) Validated and maintained grouping to assess safety topic of interest MedDRA Labelling Groupings (MLGs) Principles have been developed, but specific groupings not yet created FDA Medical Queries (FMQs): Groupings focused on labeled drug reactions and those historically known to be drug related (~100 with additional algorithmic groupings) FMQs capture those PTs indicating non drug related cause Duke Margolis Slides: https://healthpolicy.duke.edu/events/advancing-premarket- safety-analytics
2023 and Beyond Monthly Working Group meetings to coordinate white paper cohesiveness with section authors/co-authors meeting as needed Clean first draft finalized and sent for review No recommendations developed to date, stay tuned Initial audience of final white paper to be pre-marketing development but planned future expansions
PHUSE Working Groups For more information on PHUSE Working Groups, visit the Advance Hub. See volunteer opportunities in the Useful Information section. To get involved email, workinggroups@phuse.global For AEGiS specific questions: Peg Fletcher (co-lead) peg.fletcher@medassessment.com Mac Gordon (co-lead) rgordon2@its.jnj.com Katie Warren (PHUSE lead) katie@phuse.global PHUSE AEGiS
