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Project Scope

This project team will create a users guide or White Paper with recommendations for analysis 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
Charles Beasley
(
, Beasley Pharmaceutical and Biotechnology Consulting
)

Wei Wang (Eli Lilly)

wang_wei_v@lilly.com

Katie Warren (
Christopher Smith, FDAchristopher.smith2@fda.hhs.gov
Nicola Newton, PHUSE Project Assistant
)
katie@phuse

Objectives & Deliverables 

Timelines 

Final white paper (initial scope) 

Q22022


Status
colourBlue
titleCurrent Status

Q12022

White paper (initial scope) sent for public review.

Project MembersOrganisationAmelia PangSanofiDarshan BhattIndustryEdward RauschEli LillyHongli LuMerckKirthi RangarajuPfizerMary NilssonEli LillyMaria DaltonGSKMercy NavarroGenentechNancy BruckenCSGNhi BeasleyFDARaj PhadtareCorvus PharmaceuticalsRobert (Mac) GordonJanssen Research & DevelopmentSumit PradhanIndustry

Q3 2023

Project Closed.



Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023
ShayamiEli Lilly