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  • 1.  Question on stored samples prior to subject withdrawal in a clinical trial conducted in EU

    Posted 07-28-2023 12:16

    Hello,

    Can any one please guide me what happens to the biological samples that are collected prior to  the subject withdrawal in a clinical trial conducted in  EU?

    I am aware that in US if the subject withdraws from the clinical trial there samples can be used prior to the withdrawal date provided he/she has no objection but in EU is the criteria same as US?

    Any help or guidance would be greatly appreciated.

    thanks,

    Preeti



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    Preeti Dhawan
    Associate Director Biomarker and Bioanalytical
    Terns Pharma
    Foster City CA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Question on stored samples prior to subject withdrawal in a clinical trial conducted in EU

    Community Leadership
    Posted 07-28-2023 12:42
    Hi preeti,
    What matters in the US and in Europe is the consent. If the patient withdraws their consent then the samples cannot be used. Even the samples that were collected before they withdrew. However, if the withdraw from the trial but they do not withdraw their consent the samples can be used. It all matters about their consent.

    Best,
    Joel



    Original Message


  • 3.  RE: Question on stored samples prior to subject withdrawal in a clinical trial conducted in EU

    Community Leadership
    Posted 08-07-2023 17:59

    Agreed that it is all about the informed consent. It is important to ensure that the patients understand the difference between withdrawing consent versus early termination of the trial to select the option that matches their intent.

    One related challenge we have faced is what to do if a sample has already been run for a patient who subsequently withdraws consent. Since the result cannot be completely deleted due to the audit trail, we have included language in the informed consent form to acknowledge that it still exists somewhere in the audit trail even if the result is removed from subsequent data transfers.



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    Joleen White Ph.D.
    AAPS 2023 Global Health Community Past Chair
    Bioanalytical 101 Course Development
    Head of Bioassay Development
    Gates Medical Research Institute
    Cambridge MA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message


  • 4.  RE: Question on stored samples prior to subject withdrawal in a clinical trial conducted in EU

    Community Leadership
    Posted 08-08-2023 10:45

    Hi Preeti, 

    Agree with the others that consent matters and the ICF should be specific about what's happening to the data/samples. It is complicated though since there are competing regulations wherein processing of data is in the national interest (country dependent). It's especially important to maintain as much data a possible when you're in a rare or ultra-rare disease. I suggest that you engage/consult/hire a data protection officer (if you don't already have one) and they can help guide you as to what may need to be done. 

    Michele



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    Michele Gunsior
    Astria Therapeutics
    Boston MA

    The opinions expressed are my own and may not reflect those of my employer.
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    Original Message