4 ms·

So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now?

sudosysgen 5y ago
For a safety trial, likely not, but for an efficacy trial, this is pretty conclusive. In any case full approval will not be granted with even more in the way of trials.
SideburnsOfDoom 5y ago
> So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now? No. They don't have full approval, and aren't likely to get it in the next few months. From the article: > Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible Emergency Use Authorization is not full approval, and obviously comes with oversight and data gathering. "as soon as Possible" is not now. But they might get that in the next few months. Other than that, I don't know what to say about "sufficient to move forward" - any drug at any stage of trials is either abandoned or moving forward? A small trial that meets its goals is sufficient to move forward to the next trial so .. yes? But not to full approval, which they aren't getting anyway. This is an existing (but fairly new) drug so there there is other data on safety etc, links seem to be about 2019 onwards, at https://en.wikipedia.org/wiki/Molnupiravir https://en.wikipedia.org/wiki/Molnupiravir
- AndrewBissell 5y ago
  Was using "approval" colloquially, I understand the distinction between that and "authorized." However I have seen many larger trials for other repurposed drugs being tried in early treatment dumped on as "underpowered" so it's just odd that that criticism is nowhere to be found in this case. There were 7 people hospitalized in the trial group and 14 in the placebo.
  - loeg 5y ago
    The criticism is not present because this one wasn't underpowered. > p=0.0012
gus_massa 5y ago
I guess you are wondering why this is better than Ivermectin. From the article: > The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study [...] If you go to https://ivmmeta.com/ https://ivmmeta.com/ you will see: * Most of the studies have not placebo, they just compare a group of people with another unrelated group of people. It's very difficult to be sure there are no unexpected differences. * If you filter only the RCT, most of them are not statistically significant. That is a problem because if the drug has no effect, the reporting/publishing/selection bias will cause barely significant studies to accumulate. * There are only 6 that RCT that are statistically significant. Have you read them? Some have very weird things that are very big red flags. If Ivermectin has no effect, I expect like 2 of the RCT that are statistically significant to be caused by flukes. Can you pick your favorite 3?
deleted 5y ago
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caeril 5y ago
I think we/they have to. I'll don my tinfoil hat for a moment. A combination of initial vaccine effectiveness estimates having to be downgraded, and variants reducing effectiveness further, along with the infectiousness data of vaccinated carriers putting the herd immunity targets at risk have public health authorities scrambling for the next potential solution. The data out of Israel and other places is damning. Not in the sense that anti-vaxxers would like, but in the sense that we are still nowhere near containing this thing. We either need better vaccines, or drugs. So yes, epidemiological standards will relax in the face of a worldwide pandemic, to some extent.

For a safety trial, likely not, but for an efficacy trial, this is pretty conclusive. In any case full approval will not be granted with even more in the way of trials.

SideburnsOfDoom 5y ago

> So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now? No. They don't have full approval, and aren't likely to get it in the next few months. From the article: > Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible Emergency Use Authorization is not full approval, and obviously comes with oversight and data gathering. "as soon as Possible" is not now. But they might get that in the next few months. Other than that, I don't know what to say about "sufficient to move forward" - any drug at any stage of trials is either abandoned or moving forward? A small trial that meets its goals is sufficient to move forward to the next trial so .. yes? But not to full approval, which they aren't getting anyway. This is an existing (but fairly new) drug so there there is other data on safety etc, links seem to be about 2019 onwards, at https://en.wikipedia.org/wiki/Molnupiravir https://en.wikipedia.org/wiki/Molnupiravir

AndrewBissell 5y ago
Was using "approval" colloquially, I understand the distinction between that and "authorized." However I have seen many larger trials for other repurposed drugs being tried in early treatment dumped on as "underpowered" so it's just odd that that criticism is nowhere to be found in this case. There were 7 people hospitalized in the trial group and 14 in the placebo.
- loeg 5y ago
  The criticism is not present because this one wasn't underpowered. > p=0.0012

gus_massa 5y ago

I guess you are wondering why this is better than Ivermectin. From the article: > The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study [...] If you go to https://ivmmeta.com/ https://ivmmeta.com/ you will see: * Most of the studies have not placebo, they just compare a group of people with another unrelated group of people. It's very difficult to be sure there are no unexpected differences. * If you filter only the RCT, most of them are not statistically significant. That is a problem because if the drug has no effect, the reporting/publishing/selection bias will cause barely significant studies to accumulate. * There are only 6 that RCT that are statistically significant. Have you read them? Some have very weird things that are very big red flags. If Ivermectin has no effect, I expect like 2 of the RCT that are statistically significant to be caused by flukes. Can you pick your favorite 3?

deleted 5y ago

[deleted]

caeril 5y ago

I think we/they have to. I'll don my tinfoil hat for a moment. A combination of initial vaccine effectiveness estimates having to be downgraded, and variants reducing effectiveness further, along with the infectiousness data of vaccinated carriers putting the herd immunity targets at risk have public health authorities scrambling for the next potential solution. The data out of Israel and other places is damning. Not in the sense that anti-vaxxers would like, but in the sense that we are still nowhere near containing this thing. We either need better vaccines, or drugs. So yes, epidemiological standards will relax in the face of a worldwide pandemic, to some extent.