6. What special considerations pertain to imaging biomarkers?
Quality and validity of the measurement as a biomarker depends crucially on the use of a diagnostic imaging device, in a slightly different manner than in routine scanning.
Identification of the ‘objectively measured biomarker characteristic’ with a quantifiable concentration of a specified analyte may be not just impractical, but not even theoretically possible.
Qualification typically includes:
- imaging-pathology correlation in humans and preclinical models, following intervention, dose response, positive and negative control;
- cross-sectional correlation with clinical measures and other biomarkers;
- correlation with outcome.