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    Multiplicity

    Multiplicity occurs in clinical trials when a single clinical trial has several objectives, such as:

    • assessing several different doses of a treatment,
    • using several different endpoints to measure different aspects of a disease, or
    • looking at several different subgroups of patients.

    Multiplicity can affect statistical analyses and therefore undermine trial conclusions if it is not addressed.

    Multiplicity can increase the Type I error rate. A number of statistical methods can be used to control the Type 1 error rate. The methods to be used in a clinical trial should be detailed in the study protocol or the statistical analysis plan for that trial.

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