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borislvinBehind that ray of hope, though, was one of the toughest quandaries in medicine: how to balance the need to rigorously test a new medicine for safety and effectiveness with the moral imperative to get patients a treatment that works as quickly as possible.
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“There certainly was unanimity within the institute that this was the right thing to do,” said H. Clifford Lane, NIAID’s clinical director. “While I think there might’ve been some discussion, [because] everyone always tries to play devil’s advocate in these discussions, I think there was a pretty uniform opinion that this was what we should do.”
From the standpoint of the agency, he said, the study had answered the question it was designed to answer: The median time that hospitalized Covid-19 patients on remdesivir took to stop needing oxygen or exit the hospital was, at 11 days, four days shorter than those who were on placebo. “How many patients would we want to put at risk of dying,” he asked, for that last little bit of proof? Remdesivir, he noted, was not a home run, but is probably better than nothing.
Steven Nissen, a veteran trialist and cardiologist at the Cleveland Clinic, disagreed that giving placebo patients remdesivir was the right call. “I believe it is in society’s best interest to determine whether remdesivir can reduce mortality, and with the release of this information doing a placebo-controlled trial to determine if there is a mortality benefit will be very difficult,” he said. “The question is: Was there a route, or is there a route, to determine if the drug can prevent death?” The decision is “a lost opportunity,” he said.
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This is where Nissen and Bach disagree. There were 1,063 patients in the study, but only 480 had recovered at the time of the analysis. Researchers could have collected more data, they argue, and perhaps have learned if remdesivir saves lives. They were already close, both note. Results are considered “significant” if a measure called a p-value is less than 0.05; the value for mortality in the preliminary analysis was 0.059. “How many patients would we want to put at risk of dying to get that 0.01 on the p-value,” Lane retorted.
https://www.statnews.com/2020/05/11/inside-the-nihs-controversial-decision-to-stop-its-big-remdesivir-study
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“There certainly was unanimity within the institute that this was the right thing to do,” said H. Clifford Lane, NIAID’s clinical director. “While I think there might’ve been some discussion, [because] everyone always tries to play devil’s advocate in these discussions, I think there was a pretty uniform opinion that this was what we should do.”
From the standpoint of the agency, he said, the study had answered the question it was designed to answer: The median time that hospitalized Covid-19 patients on remdesivir took to stop needing oxygen or exit the hospital was, at 11 days, four days shorter than those who were on placebo. “How many patients would we want to put at risk of dying,” he asked, for that last little bit of proof? Remdesivir, he noted, was not a home run, but is probably better than nothing.
Steven Nissen, a veteran trialist and cardiologist at the Cleveland Clinic, disagreed that giving placebo patients remdesivir was the right call. “I believe it is in society’s best interest to determine whether remdesivir can reduce mortality, and with the release of this information doing a placebo-controlled trial to determine if there is a mortality benefit will be very difficult,” he said. “The question is: Was there a route, or is there a route, to determine if the drug can prevent death?” The decision is “a lost opportunity,” he said.
<...>
This is where Nissen and Bach disagree. There were 1,063 patients in the study, but only 480 had recovered at the time of the analysis. Researchers could have collected more data, they argue, and perhaps have learned if remdesivir saves lives. They were already close, both note. Results are considered “significant” if a measure called a p-value is less than 0.05; the value for mortality in the preliminary analysis was 0.059. “How many patients would we want to put at risk of dying to get that 0.01 on the p-value,” Lane retorted.
https://www.statnews.com/2020/05/11/inside-the-nihs-controversial-decision-to-stop-its-big-remdesivir-study
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Date: 2020-05-15 01:43 am (UTC)no subject
Date: 2020-05-15 01:45 am (UTC)