Table 1.

Definitions

Term	Meaning
Analytical Validity	How accurately an assay detects the analyte of interest
Clinical Validity	How well the test relates to the clinical outcome of interest
Clinical Utility	Whether the results of the test provide information that can contribute to and improve current optimal management of the patient's disease
Integral marker (or assay)	Test(s) that must be performed in order for the trial to proceed. Integral studies are inherent to the design of the trial from the onset and must be performed in real time for the conduct of the trial.
Integrated marker (or assay)	Test(s) done on all patients, or a pre-defined subset of all patients, in a clinical trial, but will NOT be used to direct treatment for that clinical trial

“Analytical Validity”, “Clinical Validity” and “Clinical Utility” defined as in reference 10