Remdesivir COVID-19 Study Evaluation Metrics Changed Last Minute to Make Standard of Care Declaration by NIAID

May 3, 2020 | Coronavirus, COVID-19, FDA Emergency Use Authorization, Gilead, Remdesivir, Standard of Care

Remdesivir COVID-19 Study Evaluation Metrics Changed Last Minute to Make Standard of Care Declaration by NIAID

First, we preface in this writing that it is a good thing that Remdesivir produced positive results. The TrialSite News research team has written many a story sharing some promising observational snippets about the anti-viral drug that was originally developed to address Ebola. There is enough evidence that the drug can in fact help the body fight the virus.  However, the results of the recent remdesivir clinical trial showcasing the positive results was actually the result of a last-minute change to the primary outcomes measures. Rather than focus primarily on the drug’s ability to keep people alive (the protocol’s primary outcome measure), the sponsors were given the greenlight to switch to the secondary outcome measure—that is, the length of time for surviving patients to recover just two weeks prior to the conclusion and Dr. Anthony S. Fauci’s proclamation to the worldthat this drug was in fact the “new standard of care.”  As noted by a recent Washington Post piece, “Death and other negative outcomes were moved to secondary measure status: They would still be tracked, but they would no longer be the key measure of remdesivir’s performance.”

Why Change the Protocol’s Evaluation Criteria Last Minute?

After all, this was declared an “adaptive trial,” and that is exactly what the trial sponsors and regulators in fact did—made an adjustment! But, changes are rarely made in this way in major clinical trials; they do happen but seldom just days or weeks before the trails’ conclusion and final federal government edicts, reports Christopher Rowland with the Washington Post.

‘Not a Knockout Drug’

Hence, on the one hand, Dr. Fauci’s signal to the medical establishment that remdesivir is a “standard of care” based on the evidence-and hence immediately thereafter the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the new “standard of care” and hence opening up the sales of the drug. But seemingly wanting to get the other side out there—perhaps to clear the conscious—the head of the National Institute of Allergy and Infectious Diseases (NIAID) noted, as reported in the Washington Post  “that remdesivir is not a knockout drug that will change the trajectory of the coronavirus pandemic.”

Government Rational

The actual change is easy to explain according to some: with a novel dangerous rapidly spreading pathogen with such uncertainty around how its lethal effects even manifest in patients that the NIAID’s decision was rational on its face—why not make the simpler secondary measure the actual primary outcome measure? This makes sense right?

The Standard of Care

In the end, remdesivir on average helped patients sick with COVID-19—on average the time to recover declined in the remdesivir group from 15 days to 11 days or a 31% improvement. That’s a good start but let’s hope the standard of care can get considerably better.

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1 Comment

  1. peter faletrs

    Any well schooled middle school student of science wouldn’t let it fly to change the metric for the outcome of an experiment once the experiment began. It is also not a stretch to know who is in what group in a blinded study. People who run blinded studies with humans know the numerous challenges of effectively blinding a study. If any deleterious effects of the treatment drug are known the patients are typically told ahead what they are for ethical reasons. Lastly, to state that this drug is not a game changer with its p-value in mortality showing no statistical difference between placebo and test group, is an unfortunate understatement.

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