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Posted On: 08/16/2020 3:10:34 PM
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Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected (Part 2)
Both companies rushed to develop their products in record time and began large studies this summer at dozens of hospitals and clinics around the country. They are testing various groups of patients, such as those who are positive but not yet sick enough to be hospitalized, and those who have been exposed to the virus from someone already infected. All of the trials compare the experimental drugs to a placebo, or sham treatment.
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The fast-moving disease has presented opportunities and challenges for the researchers testing antibodies. As the number of infections mounted in states like Florida, Texas and Arizona, there was no shortage of patients who would be eligible for trials. But at the same time, the outbreaks overwhelmed the very hospitals that would be overseeing the studies.
In remote meetings with doctors at trial sites around the country, Dr. Skovronsky said some had to step out to care for patients who required emergency intervention.
“That doesn’t happen when you’re setting up diabetes trials or cancer trials,” he said. “We’ve had investigators say: ‘Look, I’d love to do research, but I don’t have time to set up a new trial. I’ve got an I.C.U. full of patients.’”
One major hurdle has been testing. In both of the outpatient trials run by Eli Lilly and Regeneron, doctors must compete with a ticking clock. According to the rules of the Regeneron trial, a patient must be treated with the antibodies within seven days of the onset of symptoms. Both the Regeneron and Eli Lilly trials require giving the drug within three days of taking a positive test.
But with turnaround times in some areas lagging for five days or more, keeping within those time frames has proved difficult.
Both companies rushed to develop their products in record time and began large studies this summer at dozens of hospitals and clinics around the country. They are testing various groups of patients, such as those who are positive but not yet sick enough to be hospitalized, and those who have been exposed to the virus from someone already infected. All of the trials compare the experimental drugs to a placebo, or sham treatment.
Latest Updates: The Coronavirus Outbreak
Updated 7h ago
A teachers’ strike closes down a school district in Arizona that was set to begin classes on Monday.
The F.D.A. gives emergency approval for a new spit test as U.S. testing stalls.
South Korea warns of another outbreak tied to a church.
More live coverage: Markets
The fast-moving disease has presented opportunities and challenges for the researchers testing antibodies. As the number of infections mounted in states like Florida, Texas and Arizona, there was no shortage of patients who would be eligible for trials. But at the same time, the outbreaks overwhelmed the very hospitals that would be overseeing the studies.
In remote meetings with doctors at trial sites around the country, Dr. Skovronsky said some had to step out to care for patients who required emergency intervention.
“That doesn’t happen when you’re setting up diabetes trials or cancer trials,” he said. “We’ve had investigators say: ‘Look, I’d love to do research, but I don’t have time to set up a new trial. I’ve got an I.C.U. full of patients.’”
One major hurdle has been testing. In both of the outpatient trials run by Eli Lilly and Regeneron, doctors must compete with a ticking clock. According to the rules of the Regeneron trial, a patient must be treated with the antibodies within seven days of the onset of symptoms. Both the Regeneron and Eli Lilly trials require giving the drug within three days of taking a positive test.
But with turnaround times in some areas lagging for five days or more, keeping within those time frames has proved difficult.
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