Sometimes it becomes clear after you start that the registration is incomplete or wrong. Sometimes you have a better idea after you start. Sometimes your thinking changes. Other times, you're trying to cherry-pick the results.
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None of that may come to fruition. Maybe everything is fine. I WOULD LIKE THAT TO BE THE CASE. But this is presently the most important clinical trial on the planet, and that means it deserves every possible aspect of reasonable scrutiny.
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Clinical trials are a vicious way to make a living. Expensive, time-consuming, difficult, and miserable. To run one this size, in DAYS, is *an astonishing effort*. Look at the list of enrolled sites. All of em need comms, ethics, protocols, drugs, data reporting platforms etc...
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I would hate for the phenomenal hustle on display here to lack the appropriate impact, one way or the other.
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UPDATE: via DM it is pointed out they had independent oversight, and this decision was definitely reviewed. Good. Excellent. Maybe there's a great reason for the above. Let's assume said board was both independent and responsible. https://www.nidcr.nih.gov/research/human-subjects-research/interventional-studies/data-and-safety-monitoring-board-guidelines …
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That does not obviate releasing these results via press release, or explain why the changes - which, I'm assuming, were requested by the researchers - were made. A DSMB doesn't just parachute in a specific new analytical question themselves, do they?
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So, again: let's see the paper, and how it's described there. And the data, please and thank you.
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UPDATE: of course, because this is Twitter, someone else noted this HOURS ago. Full credit to
@ExcludedMuddle and@walidgellad and presumably others who were getting into the guts of this while I was eating a sandwich and watching old Tommy Hearns fights on my lunch break.Show this thread -
For more chat, have a go at this as well.https://twitter.com/walidgellad/status/1255581527972417536 …
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UPDATE: pot now officially calling for an explanation of potential soot and calcium deposits on kettle. h/t
@gorskonhttps://twitter.com/raoult_didier/status/1255835517511483394 …
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UPDATE: the OG
@garyschwitzer with a little more on the background. My shite radar is still going off, maybe even pinging a little louder.https://www.healthnewsreview.org/2020/04/what-the-public-didnt-hear-about-the-nih-remdesivir-trial/ …Show this thread -
UPDATE: here's an explanation for the outcome switching. Big ups for
@megtirrell for retrieving it. This is *at least* plausible.https://twitter.com/megtirrell/status/1255960631892721666 …
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And this is why I said "Sometimes you have a better idea after you start. Sometimes your thinking changes." Because it goddamn does. Ask anyone who's done a messy clinical trial. Put them on a pedestal all you want, they're still fraught. HOWEVER.
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I would note that today we're now talking about plausible defenses of the study protocol changes... in the absence of the study. With still nothing more than a press release and a cryptic trial registration. "Trust but verify"? We cannot.
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End of conversation
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