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Biomarker Endpoints

Meaning

Biomarker endpoints represent measurable biological characteristics used in clinical trials and practice to indicate normal processes, disease states, or pharmacological responses to a therapeutic intervention. These are distinct from traditional clinical endpoints, which directly measure how a patient feels, functions, or survives. A biomarker can be a physiological measurement, a laboratory test result from tissue or fluid, or a genetic indicator. The use of these metrics allows for a more granular and often earlier assessment of a treatment’s effect on a biological pathway or disease mechanism.