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Project Scope

This Project team will create a White Paper with recommendations for Treatment Emergent Definitions, with a focus on Phase 2-4 clinical trials. This White Paper will build upon a White Paper that outlines results from a survey on current practices, indicating variation that can likely be reduced. Recommendations will

be 

be based on the desired end-in-mind, and may or may not be consistent with current practices.



Project LeadsEmails

Mary Nilsson, Eli Lilly

nilsson_mary

-

_e@lilly.com

William Palo, Abbvie

william.palo@abbvie.com

Wendy Dobson (

Nicola Newton, PHUSE Project

Manager)

Assistant

wendy@phuse

nicky@phuse.global


Status
colourBlue
titleCurrent Status

 Q12021The team are currently developing the scenarios for their survey and are working on an abstract for the EU Connect

Q2 2024

  • Draft white paper was reviewed by the PHUSE office and submitted for public review.



Objectives &

Deliverables

Deliverables 

Timelines
Timelines 
White Paper with recommended definition(s).Q42021Project MembersOrganisationAlan ShapiroFDABeilei XuSanofiCarolyn SetzeAbbVieCathy BezekAstellasCharles BeasleyMNSElisa YoungSouthern Star ResearchJames GaiserPrometrikaJoanne ZhouGSKJun LiSanofiKim MusgraveAmgenProject MembersOrganisationLaura GoebelJanssen Research & DevelopmentMelvin MunsakaAbbVieMeredith ChuckFDANancy BruckenCSGPranab MitraIndustryRaj PhadtareCorvus PharmaRamaiah MuvvalaInductive Quotient AnalyticsRobert (Mac) GordonJanssen Research & DevelopmentRussell NewhouseEli LillySimin K BayganiEli LillyTejas PatelBooz Allen Hamilton

Project team review final White Paper 

Q2 2023
PHUSE Steering Committee & Public Review Q3 2023
Publish White PaperQ4 2023