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Under the IVDR, Lab selection for a phase 2 study

  • 1.  Under the IVDR, Lab selection for a phase 2 study

    Community Leadership
    Posted 03-16-2023 10:38

    We plan to conduct a screening assay for participant selection in a Phase 2 trial across EU countries for prophylactic treatment. The assay is only available in a US-based lab. It appears that the new IVDR mandates using an EU-based testing lab for the in-house development device. Have you encountered a similar situation, and if so, how did you handle it?


    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Under the IVDR, Lab selection for a phase 2 study

    This message was posted by a user wishing to remain anonymous
    Posted 03-17-2023 07:57
    This message was posted by a user wishing to remain anonymous

    Mark,

    The Eu's IVDR regulation is causing problems for many companies and laboratories.  The backlog with the reviewers to obtain approval is very long, and only complicates the situation. The laboratories that meet the characteristics defined in the regulation to perform the work as medical facilities are a limited group; one that does not include most bioanalytical and a number of CRO clinical labs in Europe (much less those outside of the EU). Combined together, the situation is one that will likely limit some studies from including EU subjects.  I have heard that the EU regulators are taking a risk based approach to the reviews, but that doesn't necessarily make it any easier for clinical studies.

    If you find a solution, I'm sure many AAPS members would love to hear about it. 


    Original Message


  • 3.  RE: Under the IVDR, Lab selection for a phase 2 study

    Posted 03-17-2023 09:21

    Hi Mark, 

    I used a Lab Developed Test (LDT) in an US-based lab for global clinical trial enrollment, including EU. The assay had IDE approval and was CE marked. I wasn't aware that there is such a requirement under IVDR and no health authority commented on it. Can you point to the relevant section in the document that says it is a requirement? Also, would that mean that it just needs to be in the EU, or do you need to inform each Notified Body?   

    Best wishes, Joe



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    Johannes Stanta
    Global Director Molecular and Cell Biology
    Celerion
    Lincoln NE
    [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: Under the IVDR, Lab selection for a phase 2 study

    Community Leadership
    Posted 03-21-2023 08:14

    Hi Joe, 

    My understanding is that the issue is with assays that are not CE marked in the EU. For example, if you are using an LDT or FDA approved assay, but your assay isn't CE marked in compliance (or in transition period exemption) with the CE-IVDR 2017/746 then it could be an issue to utilize data from that assay as an IVD to inform patient treatment decisions. 

    Stephanie 



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    Stephanie Cape PhD
    Head of R&D, Clinical Trials Testing Solutions
    Labcorp Drug Development
    Madison WI
    [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


  • 5.  RE: Under the IVDR, Lab selection for a phase 2 study

    Community Leadership
    Posted 03-22-2023 14:06

    Thanks for all the comments! Much appreciated. Forwarding a communication from EFPIA: New EU in vitro regulations delaying clinical trials.


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


  • 6.  RE: Under the IVDR, Lab selection for a phase 2 study

    Posted 03-19-2023 12:40

    We're struggling with this issue too! I'm not sure what to do just yet. Hope someone here has experience to share.



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    Heather Myler Ph.D.
    Senior Director
    Takeda
    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


  • 7.  RE: Under the IVDR, Lab selection for a phase 2 study

    Community Leadership
    Posted 03-20-2023 13:12

    Seems like a good topic for an upcoming Open Scientific Discussion?

     

    Have to say that this is the first time I have been relieved that Gates MRI doesn't run trials in Europe. ��

     

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    Joleen White Ph.D. (she/her)
    AAPS 2023 Global Health Community Past Chair
    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


  • 8.  RE: Under the IVDR, Lab selection for a phase 2 study

    Community Leadership
    Posted 03-21-2023 08:05

    I agree, this is a great topic of discussion that many of us are challenged by. I think there would be a lot of interest in an OSD on this.



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    Stephanie Cape PhD
    Head of R&D, Clinical Trials Testing Solutions
    Labcorp Drug Development
    Madison WI
    [email protected]

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

    Original Message


  • 9.  RE: Under the IVDR, Lab selection for a phase 2 study

    Community Leadership
    Posted 03-22-2023 14:08

    Thanks for all the comments! Much appreciated. Forwarding a communication from EFPIA: New EU in vitro regulations delaying clinical trials.




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


  • 10.  RE: Under the IVDR, Lab selection for a phase 2 study

    Posted 03-23-2023 08:13

    Mark-

    If you go to the EFPIA website (https://efpia.eu/news-events/the-efpia-view/statements-press-releases/new-european-legislation-designed-to-protect-patients-is-delaying-clinical-trials-for-thousands-of-people-with-cancer-and-rare-diseases/) the original new release is posted.  It includes a link to the actual member survey that contains much more detailed data (https://efpia.eu/media/677143/efpia_ivdr-survey-slides.pdf).

    Regards,



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    Mark Arnold Ph.D., FAAPS
    Westampton, NJ
    [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