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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 based on the desired end-in-mind, and may or may not be consistent with current practices.



Project LeadsEmails

Mary Nilsson

(

, Eli Lilly

) (

, Abbvie

) (

, PHUSE

,

Project Assistant

)


Status
colourBlue
titleCurrent Status
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

Status
colourBlue
titleCurrent Status
Q1 2023

Working on a White Paper

Project MembersOrganisationAlan ShapiroFDABeilei XuSanofiCarolyn SetzeAbbVieCathy BezekAstellasCharles BeasleyMNSElisa YoungSouthern Star ResearchJames GaiserPrometrikaJoanne ZhouGSKJon HaddadGSKJun LiSanofiKim MusgraveAmgenProject MembersOrganisation

Kirthi Rangaraju

PfizerLaura GoebelJanssen Research & DevelopmentMelvin MunsakaAbbVieMeredith ChuckFDAMonali Desai Alkermes Nancy BruckenCSGPranab MitraIndustryRaj PhadtareCorvus PharmaRamaiah MuvvalaInductive Quotient AnalyticsRobert (Mac) GordonJanssen Research & DevelopmentRussell NewhouseEli LillyShraddha GanooICON plcSimin K BayganiEli LillyTejas PatelBooz Allen HamiltonTiffany Davis Gillead