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Project Scope

This project team will create a users guide or White Paper with recommendations for analysis and displays for Laboratory Data, with a focus on Phase 2-4 clinical trials and integrated submission documents. There have been 2 previous White Papers on this topic (1 for central tendency in 2013 and 1 for Outliers/Shifts in 2015). This paper will combine two method types and update recommendations given the advancement in interactive options. 

Project LeadsEmail

Wei Wang

Paula Rowley (PHUSE Project Assistant) 


Draft white paper is progressing.

The goal is to have the white paper ready for Steering Committee Review in Q22022

Objectives & DeliverablesTimelines
Users guide or White PaperQ32021
Project MembersOrganisation
Amelia PangSanofi
Darshan BhattIndustry
Edward RauschEli Lilly
Hongli LuMerck
Mary NilssonEli Lilly
Maria DaltonGSK
Mercy NavarroGenentech
Nancy BruckenCSG
Nhi BeasleyFDA
Raj PhadtareCorvus Pharmaceuticals
Robert (Mac) GordonJanssen Research & Development
Sumit PradhanIndustry
ShayamiEli Lilly
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