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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@phuseeuDeliverables


Status

Timelines

colour

Project Members

Blue

CompanySimin K BayganiLilly

title

Alan ShapiroFDABeilei XuSanofiCathy BezekAstellasElisa YoungSouthernStarResearchJames GaiserPrometrikaJoanne ZhouGSKJuan LiSanofiKim MusgraveAmgenLori Van MeterJNJMelvin MunsakaAbbvieNancy BruckenCSG-IncPranab MitraIndustryRamaiah MuvvalaInductivequotientRussell NewhouseLilly

Current Status
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