Clinical Trials Stalling as COVID-19 Overwhelms Healthcare Systems

As coronavirus disease 2019 (COVID-19) causes medical systems to bog down from a host of related issues, a UT Health expert said clinical trials likely will be powered down and hospitals will put consideration of newly available agents on hold.

Clinical trials for biosimilars and other agents are likely to slow down, if not stall, as coronavirus disease 2019 (COVID-19) wends its course, said Jim M. Koeller, MS, a professor of pharmacotherapy with the Graduate School of Biomedical Studies at UT Health in Austin, Texas.

“The clinical trials will be the easiest thing to put on hold. I don’t see a new trial starting until some of this stuff levels out,” he said in an interview with The Center for Biosimilars. “We’re still talking about supplies of masks and gowns.”

Similarly, new agents that become available for use following FDA approval will likely not find their way into circulation within medical institutions because the resources needed to conduct the extensive internal reviews by pharmacy and therapeutics committees simply are not available at this time, he said.

What’s more likely is that hospitals and clinics will devote their energies to attending to the patients expected to become sickened by COVID-19. In addition, clinical trial activity will be downsized for weeks, possibly months, until conditions normalize, he said.

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