Many decisions for cancer patient management depend on information derived from clinical laboratory tests in addition to that derived from the clinical evaluation of these patients. At this workshop, participants will discuss and debate the definition of clinical utility for oncologic treatment, the evidence needed to demonstrate clinical utility for a molecular diagnostic, how that evidence should be obtained, and how NCI can best assist in the demonstration of clinical utility in the context of clinical trials. NCI will use this workshop to inform decisions about its role in this endeavor. The workshop format will be primarily interactive, with most of the time devoted to small focused breakout discussion groups.
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