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  • 1.  Clinical Performance Study (IVDR) - Sample size selection

    This message was posted by a user wishing to remain anonymous
    Posted 25-Aug-2023 09:03
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I'm looking for a little guidance in selecting a suitable sample size for a Clinical Performance Study (EU - IVDR). I realise that this is dictated by Statistical considerations, but can anyone provide a link to the most useful guidance documents for this? I know there are some FDA and CLSI but what can anyone suggest the most useful or alternatives? ISO20916 leaves this somewhat open.

    Thanks



  • 2.  RE: Clinical Performance Study (IVDR) - Sample size selection

    Posted 27-Aug-2023 11:10

    Anon,

    This can vary much depending on the assay, type of performance study, and the population of the disease condition.  I would suggest looking at the CLSI library as there are some individual standards there which give some assistance on determining samples necessary for different type of performance studies being performed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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