Table 1.
Type of Biomarker | Definition | Pain Examples (present; future) |
---|---|---|
Diagnostic | To detect or confirm the presence of a disease or condition. | QST; EEG; intra-epidermal nerve fibre density; |
microneurography; neuroimaging, Genetics | ||
Monitoring | To assess status of a disease or condition or effect of a medical product by any biomarker that is measured serially. | QST; compound levels in plasma, CSF; |
Neuroimaging; EEG; intra-epidermal nerve fibre density | ||
Pharmacodynamic/Response | To show that a biological response occurs in an individual exposed to a medical product. | QST; neuroimaging; EEG; Changes in cytokines |
Specific mechanistic/biochemical pain drivers; intra-epidermal nerve fibre density | ||
Predictive | To identify individuals more likely than individuals without the biomarker to experience a favourable or unfavourable effect from exposure to a medical product. | Genetics |
Neuroimaging; EEG; intra-epidermal nerve fibre density | ||
Prognostic | To identify likelihood of a clinical event, disease recurrence or progression in patients with disease of interest. | Genetics |
Neuroimaging; EEG; intra-epidermal nerve fibre density | ||
Safety | Measured before or after an exposure to a medical product to indicate likelihood, presence or extent of toxicity. | Treatment related e.g. sedation, tolerance, constipation, respiratory depression |
Neuroimaging; EEG | ||
Susceptibility/Risk | Potential for developing a disease or medical condition | Genetics |
Neuroimaging; EEG |
Adapted from “BEST (Biomarkers, Endpoints, and other Tools) Resource”, a publication produced by the joint FDA-NIH Biomarker Working Group, December, 2016 (BEST, 2016)