Primary endpoint

    In Trial design & structure

    The primary endpoint is the single main measurement a trial is designed and sized to answer. Success or failure is judged on it, and the sample size is calculated for it. Trials normally have just one, because testing many outcomes as if each were primary inflates the chance of a false positive.

    Why it matters

    A trial that misses its primary endpoint is generally treated as a negative trial, even if several secondary endpoints look encouraging.

    Example

    In a heart-failure trial, the primary endpoint is the number of participants who die from cardiovascular causes or are hospitalized for heart failure within 24 months.

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