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Hard Endpoints

Meaning

Hard Endpoints are objective, unambiguous, and clinically significant measures used in clinical trials to definitively assess the efficacy or safety of a therapeutic intervention, such as a new hormonal treatment protocol. These outcomes typically represent definitive clinical events that are indisputable, easily measured, and directly relevant to patient survival and morbidity, including all-cause mortality, myocardial infarction, or stroke. They are considered the gold standard for evidence generation because they are less susceptible to subjective bias or measurement variability than surrogate markers.