Minimizing the Gap Between Clinical Trial Data and Real-world Outcomes

Romney Humphries, PhD, D(ABMM), section chief of Clinical Microbiology at the University of California, Los Angeles, discusses the importance of minimizing the gap between clinical trial data and real world outcomes.

Interview Transcript (slightly modified for readability)

“I think that as diagnostic manufacturers are developing these technologies, it’s really important for them to keep in mind that they need to have a clinical outcome portion to their trials.

Currently, trial design for in vitro diagnostic devices in the United States is predominantly comparing method A to method B in the lab, but it doesn’t always, or really ever, step outside the lab to look at what could potentially happen with the patient with this test. I think through either clinical trials or follow-up studies, we need to have these real world studies to evaluate randomizing patients to standard of care versus rapid diagnostics and how that impacts the overall outcomes and cost associated with the care of these patients.”