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Project Scope 

Clarify

The Project has successfully completed the first step of clarifying the definitions and labels

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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). 



    Project LeadsEmail
    Nathalie van Borrendam, Johnson & Johnsonnvanborr@its.jnj.com
    Annett Keller, Boehringer Ingelheim annett.keller@boehringer-ingelheim.com
    Alex Pearce, PHUSE Project Assistant 

    Alexandra@phuse.global


    Status
    colourBlue
    titleCurrent Status
    Q2 2023 Q3 2023

    • Submitted abstract for the PHUSE US Connect 2024. 
    • Applied for workshop at the PHUSE US Connect 2024. 
    • Development of second white paper.  
    • First paper accepted at TIRS. 
    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