Secondary outcome measure

Secondary outcome measure refers to a planned outcome measure that may provide supportive information about a therapy’s effect on the primary endpoint or demonstrate additional effects on the disease or condition. In other words, a secondary outcome measure is not as important as the primary outcome measure for evaluating the expected primary effect of a therapy being studied but may provide support. Alternatively, secondary outcome measures may be part of the protocol to evaluate the secondary endpoint(s) associated with secondary study objectives of the study. Most clinical studies have more than one secondary outcome measure as part of its clinical study’s protocol.

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U.S. Food and Drug Administration (FDA): Multiple Endpoints in Clinical Trials Guidance for Industry