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project treatment emergent definitions    be 

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 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

 Q42020New team formed and recently presented at CSS. Will review deliverables and timelines this quarterDeliverablesTimelinesWhite Paper with recommended definition(s) Q42021Project MembersCompanyAlan ShapiroFDABeilei XuSanofiCarolyn SetzeAbbVieCathy BezekAstellasCharles BeasleyMNSElisa YoungSouthernStarResearchJames GaiserPrometrikaJoanne ZhouGSKJun LiSanofiKim MusgraveAmgenLaura GoebelJanssen Research and DevelopmentMelvin MunsakaAbbVieMeredith ChuckFDANancy BruckenCSGPranab MitraIndustryRaj PhadtareCorvus PharmaRamaiah MuvvalaInductive QuotientRussell NewhouseEli LillySimin K BayganiEli Lilly

Q2 2024

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



Objectives & Deliverables 

Timelines 

Project team review final White Paper 

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