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Time to Clinical Response as a Valuable Metric

Thomas Lodise, PharmD, PhD, discusses why "time to clinical response" is a valuable metric to use in clinical studies.

?rel=0Segment Description: Thomas Lodise, PharmD, PhD, professor at Albany College of Pharmacy and Health Sciences, discusses why "time to clinical response" is a valuable metric to use in clinical studies.

Interview transcript (modified slightly for readability):

Contagion®: Why is time to clinical response such a valuable metric?

Dr. Lodise: Clinical response is such a valuable metric because it really provides us with several cues in clinical practice. When you look at the CAP guidelines for community acquired pneumonia, when someone's clinically stable, this is a time point—if they are receiving IV drugs—to consider oral therapy and, furthermore, this is a time when you would consider discharging a patient from a hospital. Really when we think about this time to clinical response, we really think it's a surrogate for getting patients on oral who were not on oral therapy, as well as getting them out of the hospital. The 1 thing people always say is, "Well, why don't you just do length of stay comparisons in clinical trials?" These are programmatic trials; there's a fixed duration of therapy; many of the sites who enroll patients are outside the United States; and usually what they do is they keep these patients in the hospital past the end of treatment even though they're responders. When we look at length of stay in clinical trials, it's really kind of artificial. Rather, I think the better thing to do is look at time to clinical response, which is more indicative of when a patient can be put on oral therapy and when they can be discharged home.