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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
Charles Beasley
(
, Beasley Pharmaceutical and Biotechnology Consulting
)
charlesmbeasleyjr@msn.com
Christopher Smith
(
, FDA
)
christopher.smith2@fda.hhs.gov
Katie Warren (
Nicola Newton, PHUSE Project Assistant
)
katie@phuse

nicky@phuse.global

Objectives & Deliverables 

Timelines 

White Paper (initial scope) 

Q3 2022


Status
colourBlue
titleCurrent Status
Q3

/4 2022Align next steps for this project in Q1 202 

2023

Project

MembersOrganisationAmelia PangSanofiDarshan BhattIndustryEdward RauschEli LillyHongli LuMerckKirthi RangarajuPfizerMary NilssonEli LillyMaria DaltonGSKMercy NavarroGenentechMiri Kramer MediwoundNancy BruckenCSGNhi BeasleyFDARaj PhadtareCorvus PharmaceuticalsRobert (Mac) GordonJanssen Research & DevelopmentSumit PradhanIndustryShayami 

Thanabalasundrum

Eli LillyWei Wang Eli Lilly Xuewei (Sherry) Cui Eli Lilly

Closed.



Objectives & Deliverables 

Timelines 

Align on next steps 

Q2 2023