patient numbers required for clinical study , page-10

  1. 880 Posts.
    gungunno - if you are turning your back on wikipedia you are turning your back on one of the greatest free resources in the history of mankind.

    You are correct of course that it is not a Journal of Reference or an academic - standard source. But for general, run of the mill sourcing of information it is truly amazing.

    Out of interest - are you implying that you think that there will be a Phase III study for CVac with less than 300 patients?

    if you are you might like to check the following website:

    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069898.htm

    which is straight from the horse's mouth. It states that:

    Phase 3 studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people.
 
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