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  • 1.  Q&A on when the European IVDR regulation apply in clinical trials

    Community Leadership
    Posted 06-03-2022 05:25
      |   view attached

    Hi All,
    The attached Q&A was released recently to clarify when the European IVDR regulations (effective 26 May 2022) are applicable to assays used in the clinical trial space. This will likely impact biomarker assays used in precision medicine/patient identification and immunogenicity assays used to prescreen for entry into a trial, amongst many others...
    Thanks, 
    Rob



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    Robert Nelson
    Associate Director, Scientific Affairs
    Labcorp Drug Development
    Meyrin Switzerland
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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    Attachment(s)

    pdf
    mdcg_2022-10_en_25 May 22.pdf   654 KB 1 version


  • 2.  RE: Q&A on when the European IVDR regulation apply in clinical trials

    Posted 06-07-2022 01:26
    Dear Rob,
    Thank you for sharing this.
    Are you certain that this is applicable to blood sampling for ADA assays used to pre-screen for entry into a trial?
    Article 3 states:

    3. This Regulation does not apply to:

    (b) invasive sampling products or products which are directly applied to
    the human body for the purpose of obtaining a specimen;

    Thus, I do not see this applicable to blood sampling for ADA assays used to prescreen for entry into a trial.

    Could you expand on why you think it is applicable to this particular case?

    All the best
    Paul

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    Paul Chamberlain
    Immunogenicity Integrated Platform
    [email protected]
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    Original Message


  • 3.  RE: Q&A on when the European IVDR regulation apply in clinical trials

    Community Leadership
    Posted 06-07-2022 04:09
    Hi Paul,
    There has been a lot of uncertainty on how the IVDR will apply in the context of clinical trials, and I am far from an expert on this topic...
    From my understanding, if the assay is used to provide information for medical management decisions, e.g., select patients for enrolment in the trial, assign patients to a treatment arm, guide follow-up measures during and beyond the clinical trial, then it falls within scope of the IVDR.

    There's a diagram in the Q&A that seem pretty black and white (or pink and blue...)

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    Robert Nelson
    Associate Director, Scientific Affairs
    Labcorp Drug Development
    Meyrin Switzerland
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
    ------------------------------

    Original Message


  • 4.  RE: Q&A on when the European IVDR regulation apply in clinical trials

    Posted 07-14-2022 14:34
    Hi Rob and Paul,
    Very interesting discussion. I agree with Rob and thinks its very pin/blue/grey :) It depends on the intended use of the pre-screening of ADA. You also must consider if the assay will be used for clinical decision for a patient (ie compare to CLIA regulations in the US). If the assay is used to exclude patients or some form of patient stratification from being part of a trial you will not have tested the efficacy and safety of the drug under investigation in these patients. This means that the assay in phase 3 should consider the IVDR. If the assay already exist as an IVD(R) then you do not need to consider CDx development. If the assay is new then you have a high risk with a need to consider CDx. So not only for ADA but any biomarler/PK-assay/diagnostic assay you use rto stratify your patient. You must always consider how you use the results to include/exclude patients. This is the main reason why pre-existing antibodies for AAV therapies often are considered to be developed for CDx. For pre-existing ADA to a therapeutic protein this may then be the case if you exlude patients in phase 3 based on pre-existing antibodies. 
    br, Anna

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    Anna Laurén
    Principal Scientist
    Novo Nordisk A/S
    Måløv
    [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