Fig. 2.

A framework for response biomarker discovery. (A) Serial collection of any biofluid during the course of treatment. Data derived from this experimental design will demonstrate treatment-related changes in biofluids, which can be correlated with response and progression. Data will also be derived that will inform on the biomarker kinetics, including how soon changes occur with response (“1”), as well as how soon changes that indicate acquisition of resistance (“2”) appear. (B) Correlation of treatment-related alterations in biofluids with treatment response. Particularly valuable biomarkers consist of analytes that change specifically with progression (“G,H,J”) or with response (”L, M, N” and possibly “T, U, V”). Iterative experiments related to numerous clinical trials will determine whether these alterations are drugs specific