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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.

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    Project Scope 

    The Project has successfully completed the first step of clarifying the definitions and labels 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 & Johnson) nvanborr@its.jnj.com
    Annett Keller (, Boehringer Ingelheim) Ingelheim annett.keller@boehringer-ingelheim.com
    Alex Pearce (, PHUSE Project Assistant) Assistant 

    Alexandra@phusealexandra@phuse.global


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

    Status
    colourBlue
    titleCurrent Status
    Q2 2023

    Q3 2024

    • Storyline for the second White Paper have been agreed
    • Working on Developing 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