Biomarker (biological marker), indicates a substance or physical event that can be measured and correlated with health, disease or drug treatment and refers to some biological state or condition.
Biomarkers are often measured and evaluated to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
- One practical example of a macroscopic biomarker for cardiovascular disease is the measurement of blood pressure.
- At the molecular level, the expression of certain genes is used as biomarker to determine the appropriate therapy for cancer patients.
- Biomarkers are thus a key component of Personalized Healthcare approaches. Appropriate biomarkers are also essential to design clinical studies and to define their intended or expected outcome.
- Diagnostic methods aim at identifying and quantifying disease-relevant biomarkers
Conclusions:
Biomarkers play a critical role in improving the drug development process as well as in the larger biomedical research enterprise. Understanding the relationship between measurable biological processes and clinical outcomes is vital to expanding our arsenal of treatments for all diseases, and for deepening our understanding of normal, healthy physiology. Since at least the 1980s, the necessity of using biomarkers as surrogate outcomes in large trials of major diseases, such as cancer and heart disease, has been widely discussed. The FDA continues to promote the use of biomarkers in basic and clinical research, as well as research on potential new biomarkers to use as surrogates in future trials.
Biomarkers could only serve as true replacements for clinical relevant endpoints if we completely understood the normal physiology of a biological process, the pathophysiology of that process in the disease state, and effects of an intervention – pharmacological, device, or otherwise – on these processes.
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