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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

Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse

nicky@phuse.global


Status
colourBlue
titleCurrent Status

Q3/42021

Survey has been completed but left open for FDA feedback/ participation.

Have a draft completed for Q42022

Objectives & DeliverablesTimelinesWhite Paper with recommended definition(s).Q42021Project MembersOrganisationAlan ShapiroFDABeilei XuSanofiCarolyn SetzeAbbVieCathy BezekAstellasCharles BeasleyMNSElisa YoungSouthern Star ResearchJames GaiserPrometrikaJoanne ZhouGSKJon HaddadGSKJun LiSanofiKim MusgraveAmgenProject MembersOrganisationLaura GoebelJanssen Research & DevelopmentMelvin MunsakaAbbVieMeredith ChuckFDANancy BruckenCSGPranab MitraIndustryRaj PhadtareCorvus PharmaRamaiah MuvvalaInductive Quotient AnalyticsRobert (Mac) GordonJanssen Research & DevelopmentRussell 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 PatelBooz Allen Hamilton