Trial Design
Secondary Endpoint
A secondary endpoint is a pre-specified outcome measure that supports interpretation of the primary endpoint or evaluates additional treatment effects, but is not the principal basis for the trial's conclusion.
Secondary endpoints commonly include alternative efficacy measures, quality-of-life scores, biomarker changes, and key safety outcomes. They can support label claims if pre-specified, controlled for multiplicity, and tested only after the primary endpoint succeeds.
Exploratory endpoints, by contrast, are not multiplicity-controlled and are used for hypothesis generation only.
Related terms
Primary Endpoint
A primary endpoint is the pre-specified outcome measure on which a clinical trial's conclusions about efficacy or safety are principally based, used to power the sample size calculation and to test the trial's main hypothesis.
Endpoint (Clinical Trial)
A clinical trial endpoint is a defined, measurable outcome that determines whether the intervention being studied has the intended effect; it is the variable on which the trial's success or failure is statistically evaluated.
Statistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is a detailed technical document that specifies, before database lock, every statistical analysis to be performed on a clinical trial's data, including primary and secondary endpoint analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
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