Regulatory Open Forum

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  • 1.  Missed Primary Endpoint

    Posted 04-Apr-2014 15:38
    There are a few exceptions to the rule, where drugs are approved after a failed primary endpoint. Is anyone aware of a handful of them?

    Thank you,

    Rosemary Teresi, PhD, RAC
    Scientific Director
    ProEd Communications
    Beachwood OH
    United States

  • 2.  RE:Missed Primary Endpoint

    Posted 08-Apr-2014 12:24
      |   view attached

    I am not aware of any drugs that failed their primary endpoint and still got approved. However, orphan drugs in rare diseases have some flexibility in study design, patient numbers and endpoints; attached is a good article that might be helpful. If anyone else can cite an approval of a drug with a failed primary endpoint that would be interesting.


    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States