- Biomarker-Driven Randomization to Target Subjects
- Biomarker-Driven Therapies
- Blood-Brain Barrier (BBB)
- Branch Retinal Vein Occlusion (BRVO)
- Cancer Vaccines
- CAR T-Cell Therapy
- Case Report Form (CRF)
What is a Biomarker? A biomarker is a measurable, reproducible indicator of a biological process, the patient’s health, or the current state of disease. Unlike symptoms, biomarkers provide objective assessment tools that are used in a variety of ways in medicine.
How Are Biomarkers Used?
Biomarkers have several functions:
- Monitoring patients’ health
- Monitoring the state of a disease
- Predicting the risk of disease development
- Diagnosis of disease
- Measuring the efficacy of treatment
- Acting as clinical endpoints in research
Examples of Biomarkers
- Blood pressure is used to diagnose hypertension and monitor the patient’s health or response to medication.
- Prostate-specific antigen (PSA) is used to monitor prostate cancer and its response to therapy.
- The presence of BRCA 1/2 mutations is used to identify individuals at risk for developing breast cancer.
- HbA1C as a surrogate endpoint for clinical trials for the treatment of diabetes mellitus.
Source: FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK326791/ Co-published by National Institutes of Health (US), Bethesda (MD).