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Project Scope 

Clarify

The Project has successfully completed the first step of clarifying the 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.

    linked to QTL monitoring. Recommendations on how to derive thresholds for QTL monitoring have been developed.  

    The next stage shall be to: 

    • Share this acquired knowledge and common understanding within the industry. 
    • Continue the discussion on further refining the (statistical) methodology regarding threshold derivation for QTL monitoring. 

    Closely follow ICH (R3) developments regarding risk-based monitoring and discuss/evaluate whether this has impacts on the guidance provided so far (QTL vs. acceptable range). 



    Project LeadsEmail
    Nathalie van Borrendam
    (Janssen Research & Development) 
    , Johnson & Johnsonnvanborr@its.jnj.com
    Annett Keller
    (
    , Boehringer
    Ingelheim) (
    Ingelheim annett.keller@boehringer-ingelheim.com
    Paula Rowley
    Alex Pearce, PHUSE Project
    Assistant)
    Assistant 
    paula@phuse

    alexandra@phuse.global


    Status
    colourBlue
    titleCurrent Status
    Q2 2024

    • Presented paper outcomes at Phuse US Connect Feb 2024 
    • Presented paper outcomes to the Phuse-FDA meeting in March 2024 



    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
    Q2/3 2022

    Project approved.Project MembersOrganisationsAnnett KellerBoehringer IngelheimDebra JendrasekDaiichi SankyoJim WangJanssen Research & DevelopmentMarcus EeMaithy MuliMerckMarion WolfsJanssen Research & DevelopmentNathalie van BorrendamJanssen Research & DevelopmentPatrice BennerMerckStefano SainoMerckSteve YoungCluePointsSteven Andrew GilbertPfizerSusan TalbotAmgen