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How Do Clinical Trial Data Compare to Real-world Data?

Romney Humphries, PhD, D(ABMM), section chief of Clinical Microbiology at the University of California, Los Angeles, discusses the challenges of conducting clinical outcome studies to provide data to support new tests.

Romney Humphries, PhD, D(ABMM), section chief of Clinical Microbiology at the University of California, Los Angeles, discusses the challenges of conducting clinical outcome studies to provide data to support new tests.

Interview Transcript (slightly modified for readability)

“One of the challenges with all of these new technologies is they are very costly to implement, and so we’re talking about going from our traditional tests that labs perform today, which are in the order of $5 to $10 per test, to going to a test that costs in the order of $150 to $250 per organism. This is a big jump in price. And so, what we really need are good clinical outcome data to support the use of these new tests; however, to date, we’ve really been remiss and [have] not done these studies.

There’s only one randomized control trial done to date that looks at the impact of having a rapid susceptibility test. This was a study done at the Mayo Clinic by Ritu Banerjee and colleagues. In that study, they were able to show several benefits including reduced time on antimicrobials, less use of broad-spectrum antimicrobials, as well as preventing the treatment of contaminants, because [there is] a much more rapid answer [to] 'is this a pathogen or is this a contaminant?

Outside of that study, we really don’t have good outcome studies that show things like reduction in length of stay, reduction in ancillary testing while the patient’s in the hospital, [and] all these things that are really going to be important for labs to be able to justify the worth of bringing on these tests. Not to mention, we’ve yet to have a trial that’s powered enough to really look at clinical outcome based on these results, so does it actually have an impact on mortality for these patients?”