Integration of Specialized Research Services into Clinical Laboratory Operations

Remaley, Alan T.; Murray, Patrick R.; Fleisher, Thomas A.

The clinical laboratory can play a useful role in a clinical research program at multiple levels including assistance in developing a laboratory test menu during protocol design, often focused on identifying testing approaches that address specific research questions. Laboratory staff also can provide important input in test performance and test result interpretation in the setting of the specific research questions. In addition, the laboratory can collaborate with investigators in identifying available test methods or developing new testing that will be useful answering specific questions raised in the protocol. Finally, the clinical laboratory can provide important support in translating research questions into new laboratory methods that may not only be useful for the protocol but that may mature into alternative diagnostic or therapeutic applications for patient care. As a model, we outline the approach taken in our laboratory in support of clinical research performed at the National Institutes of Health (NIH) Clinical Center.