Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.


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)

nilsson_mary_e@lilly.com

William Palo

(

, 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 ChuckFDANancy BruckenCSGPranab MitraIndustryRaj PhadtareCorvus PharmaRamaiah MuvvalaInductive Quotient AnalyticsRobert (Mac) GordonJanssen Research & DevelopmentRussell NewhouseEli LillyShraddha GanooICON plcSimin K BayganiEli LillyTejas PatelBooz Allen HamiltonTiffany Davis Gillead

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