Biomarkers
Biomarkers in basic and clinical research as well as in clinical practice has become so commonplace that their presence as primary endpoints in clinical trials. Biomarkers that have been well characterized and repeatedly shown to correctly predict relevant clinical outcomes across a variety of treatments and populations; this use is entirely justified and appropriate. It is easy to imagine measurable Biological characteristics that do not correspond to patients' clinical state, or whose variations are undetectable and without effect on health. Surrogate endpoints are a small subset of well-characterized Biomarkers with well-evaluated clinical relevance. A Biomarker consistently and accurately predicts a clinical outcome, either a Benefit or harm.
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