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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

nilsson_mary-e@lilly.com

William Palo

william.palo@abbvie.com

Wendy Dobson (PHUSE Project Manager)

wendy@phuse.global


Status
colourBlue
titleCurrent Status
 Q42020

New team formed and recently presented at CSS. Will review deliverables and timelines this quarter


DeliverablesTimelines
White Paper with recommended definition(s) Q42021



Project MembersCompany
Alan ShapiroFDA
Beilei XuSanofi
Carolyn SetzeAbbVie
Cathy BezekAstellas
Charles BeasleyMNS
Elisa YoungSouthernStarResearch
James GaiserPrometrika
Joanne ZhouGSK
Juan Jun LiSanofi
Kim MusgraveAmgen
Lori Van MeterJanssen Research & Development
Melvin MunsakaAbbVie
Meredith ChuckFDA
Nancy BruckenCSG
Pranab MitraIndustry
Raj PhadtareCorvus Pharma
Ramaiah MuvvalaInductive Quotient
Russell NewhouseEli Lilly
Simin K BayganiEli Lilly
Tejas PatelFDA