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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

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 ConnectDeliverablesTimelinesWhite Paper with recommended definition(s) Q42021Project MembersCompanyAlan ShapiroFDABeilei XuSanofiCarolyn SetzeAbbVieCathy BezekAstellasCharles BeasleyMNSElisa YoungSouthernStarResearchJames GaiserPrometrikaJoanne ZhouGSKJun LiSanofiKim MusgraveAmgenLaura GoebelJanssen Research & DevelopmentMelvin MunsakaAbbVieMeredith ChuckFDANancy BruckenCSGPranab MitraIndustryRaj PhadtareCorvus PharmaRamaiah MuvvalaInductive QuotientRussell NewhouseEli LillySimin K BayganiEli LillyTejas PatelFDA

Q3 2024

  • Engaged graphics vendor to start finalisation of white paper.



Objectives & Deliverables 

Timelines 

White Paper - Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials'

Q3 2024