Translational Laboratory Medicine
Given the lack of a precise definition, and aided by a fluidity of application whereby observations made at the bench are “translated” to the bedside and vice versa, many can claim to conduct translational research. To quote Dr. Steven Woolf in a 2008 commentary published in the Journal of the American Medical Association, “Translational research means different things to different people, but it seems important to almost everyone”. In the early 2000s, the Institute of Medicine's Clinical Research Roundtable classified translational research into 2 major blocks. T1 is defined as “the transfer of new understandings of disease mechanisms gained in the laboratory into the development of new methods for diagnosis, therapy, and prevention and their first testing in humans,” and T2 is “the translation of results from clinical studies into everyday clinical practice and health decision making”. Within academic medical centers, the T1 block has received most of the attention.
The clinical laboratory professional is well positioned to provide leadership in translational research. Expertise in the principles of good laboratory practices, access to patient specimens, and an appreciation for regulatory standards make the clinical laboratory professional well suited to provide consultation and/or oversight of preclinical studies aimed at the validation of observations made at the bench in patient-derived specimens (blood, urine, biopsies, etc.). Moreover, access to clinical data allows for the required clinical and pathologic correlations to be performed.
The clinical laboratory professional may also play an important role in biomarker studies typical of early clinical trials, in which identification of biomarkers for monitoring safety, responsiveness, efficacy, and patient stratification and prognosis are essential. Here, combined knowledge of pathophysiology and measurement science provides the clinical laboratory scientist with an advantage.
Journal of Clinical chemistry and Laboratory Medicne