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Project Scope 

  • Clarify definitions and labels.
  • Experience sharing of methodologies used to set thresholds for QTL parameters with a clear link to the scientific question of the clinical trial.
  • Develop a guidance for threshold-setting methodologies for QTL parameters with a clear link to the scientific question of the clinical trial.



Project LeadsEmail
Nathalie van Borrendam(Janssen Research & Development) nvanborr@its.jnj.com
Annett Keller(Boehringer Ingelheim) annett.keller@boehringer-ingelheim.com
Paula Rowley(PHUSE Project Assistant)

paula@phuse.global


Objectives & DeliverablesTimelines
Challenges in QTL threshold setting – Experience sharing and high-level recommendations for the industryQ3 2022

Guidance document on QTL threshold-setting methodologies

Q1 2023


Status
colourBlue
titleCurrent Status
Q3/4 2022

During the PHUSE EU Connect, Working Group Working Group members will meet to kick off the white paperwhite paper.



Project MembersOrganisations
Annett KellerBoehringer Ingelheim
Debra JendrasekDaiichi Sankyo
Jim WangJanssen Research & Development
Marcus EeMaithy MuliMerck
Marion WolfsJanssen Research & Development
Nathalie van BorrendamJanssen Research & Development
Patrice BennerMerck
Stefano SainoMerck
Steve YoungCluePoints
Steven Andrew GilbertPfizer
Susan TalbotAmgen