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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
Lauren White (PHUSE Project Coordinator) 

lauren@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
Q1 Q2 2023

Drafting of the white paper.

Finalisation of guidance document on QTL- Threshold setting methodologies is being reviewed



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