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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

nilsson_mary-e@lilly.com

William Palo, Abbvie

william.palo@abbvie.com

Paula Rowley (

Nicola Newton, PHUSE Project Assistant

)

paula@phuse 


Status
colourBlue
titleCurrent Status

 Q22021Survey has been completed and went out to a sample for testing. Hoping to finalise the survey and send to a broad audience in Q3

Q3 2024

  • Engaged graphics vendor to start finalisation of white paper.



Objectives &

Deliverables

Deliverables 

Timelines
Timelines 

White 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 LillyTejas PatelBooz Allen Hamilton