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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

) (

, Abbvie

)Katie Warren (

Nicola Newton, PHUSE Project Assistant

)

katie@phuse

Objectives & Deliverables 

Timelines 

Finalise the summaries from the survey results

Q2 2022Draft White PaperQ3/4 2022


Status
colourBlue
titleCurrent Status

Q3/4 2022

Draft white paper by Q3/early Q4. Writing is underway, with work expected to continue into Q1 2023. 

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 Hamilton

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
Tiffany Davis Gillead