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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
Alex Pearce (PHUSE Project CoordinatorAssistant) 

Alexandra@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2023

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



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
Q2 2023

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

Project MembersOrganisationsAnnett KellerBoehringer IngelheimArseny KhaplanovParexelDaniel Kowalski ClinscienceDebra JendrasekDaiichi SankyoJim WangJanssen Research & DevelopmentMarcus EeMaithy MuliMerckMarion WolfsJanssen Research & DevelopmentMarta KozińskaAstrazenecaNathalie van BorrendamJanssen Research & DevelopmentPatrice BennerMerckStefano SainoMerckSteve YoungCluePointsSteven Andrew GilbertPfizerSusan TalbotAmgenYu Meng Merck