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Project Scope 

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  • 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). 



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

    Alexandra@phuse.global


    Status
    colourBlue
    titleCurrent Status
    Q4 2023

    • Developing the 2nd White Paper 



    Susan TalbotAmgenDuring the PHUSE EU Connect,Working Group members will meet to kickoff the white paper.
    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

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