Definition of biomarkers and efficacy end-points
Biomarkers are indicators that measure normal processes or disease processes in the body. This might include an individual’s response to a medicine.
- Biological substances (‘biochemicals’), such as enzymes or hormones - these may be found in the blood or in tissue samples (biopsies).
- Gene changes.
- Images from Magnetic Resonance Imaging (MRI).
Biomarkers can be any measurements that can reliably be made and that can tell us something about a person’s health or disease state. This might include the persons’ response to a therapy. It has to be considered that levels of specificity and sensitivity of a given marker may vary widely.
- Specificity – this is the proportion of ‘negatives’ which are correctly identified.
- Sensitivity – this is the proportion of ‘positives’ which are correctly identified.