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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.

eu

global


Status
colourBlue
titleCurrent Status

 Q42020New team formed and recently presented at CSS. Will review deliverables and timelines this quarterDeliverablesTimelines

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
Project MembersCompanyAlan ShapiroFDABeilei XuSanofiCathy BezekAstellasElisa YoungSouthernStarResearchJames GaiserPrometrikaJoanne ZhouGSKJuan LiSanofiKim MusgraveAmgenLori Van MeterJNJMelvin MunsakaAbbvieNancy BruckenCSG-IncPranab MitraIndustryRamaiah MuvvalaInductivequotientRussell NewhouseLillySimin K BayganiLilly