10/n This makes absolutely no sense to me. These people were randomized and treated, and they met the inclusion criteria pre-registered by the authors. Why were they excluded?
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11/n If you add these people back in, the results of the study entirely lose their significance At day 10, this would be 87% of the ivm and 77% of the control reaching the primary endpoint, p=0.16pic.twitter.com/UjgaGpjYFw
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12/n In addition, the authors pre-registered 3 primary outcomes. I can only see one (viral clearance) properly assessed in the paper (shedding is somewhat assessed, but it looks like they didn't get enough samples to statistically analyse this)pic.twitter.com/wv4hnBhNNE
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13/n Anyway, the main issue is that, if you use the pre-registered protocol, the study appears to have null results And yet, reported as positive to massive worldwide acclaim
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14/n This has nothing to do with fraud, takes literally minutes to check, and I encourage everyone to do so. Please let me know if I've made an error somewhere
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15/n Also, to be clear - I'm not accusing the authors of any research misconduct, this is just very basic due diligence that everyone should do for any trial that they read
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16/n Also worth noting that it is entirely possible the study still has some positive results when you add these patients back in - the point is their primary outcome, which is the main thing reported, seems to change substantially when these people are included!
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Replying to @GidMK
I'd simply say that the investigators should have gone to their IRB and filed a protocol amendment request if they determined the original protocol needed to be amended (it did - it makes no sense to enroll Ct > 35 into this trial).
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Replying to @EdoajoEric
If this had happened as the study was running, and they presented analyses with both patient populations, sure. But instead we've just got the one analysis that appears to have been decided on after the study finished
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Replying to @GidMK
In which case the orginal should be written up and presented as studied, and the new analysis with new criteria done as post hoc, which would require IRB approval.
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Lol sounds like we're agreeing
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