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  • 1.  Clinical Trial Design for De Novo

    Posted 04-Oct-2020 05:44
    Hi All!

    This is my first time using the forum so thanks to everyone in advance!

    I have a client who would like to know if SCED (single case expiremental design) studies with randomized baslines (in this case. a meta analysis of mutlple single case expirmental design trials from different sites) would be an acceptable trial design for a digital theraputic De Novo submission. Here are two links that might fill in the question a bit:

    https://www.gov.uk/guidance/n-of-1-study-comparative-studies

    https://www.gov.uk/government/collections/evaluating-digital-health-products

    I'd appreciate any help I can get here. Feel free to message me directly at josh.a.vanderiet@gmail.com if it is more convenient.

    Much appreciated!

    Josh Van De Riet


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    Joshua Van De Riet
    Modi'in
    Israel
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  • 2.  RE: Clinical Trial Design for De Novo

    Posted 06-Oct-2020 07:30
    Hello All!

    Just figured I would through this out there again to see if I get any takers! Would appreciate some help in how FDA thinks about clinical trial design for De Novos!

    Thanks!

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    Joshua Van De Riet
    Modi'in
    Israel
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    Original Message


  • 3.  RE: Clinical Trial Design for De Novo

    Posted 07-Oct-2020 09:30
    Hello,

    I think it would depend on the aims of the meta analysis.  Within a DeNovo application, you are basically asking for a new product code because there isn't one in existence.  As such, the application is based heavily upon risk documentation.  If the trials included have safety as an outcome, it's possible but I would meet with FDA via Pre Sub and present your trial design and objectives.

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    Gretchen Upton CQA, CCRP, RAC
    RA/QA
    Helotes TX
    United States
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    Original Message


  • 4.  RE: Clinical Trial Design for De Novo

    Posted 14-Oct-2020 17:32
    Joshua

    If contemplating a De Novo you really need to speak to FDA via a formal presub.  De Novo  will always require clinical data (as you have no predicate from which to infer clinical safety and performance).  FDA' s approach is simple - YOU need to justify what clinical data will be adequate, and convince FDA.  So you need to build your case, based on the science, present that to FDA and get their feedback and, hopefully, concurrence.   It will depend entirely on your device type.

    Also do be aware of the conservative approach of FDA to having clinical data generated in USA.

    Message me directly if you need assistance.  We are used to doing these presubs for De Novos.

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    www.brandwoodckc.com
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    Original Message


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