This study is a common citation of ivermectin believers, has been reported widely, and I think is a great teaching tool in how little effort it takes to be critical about research findings 1/npic.twitter.com/YDZNB1JP5R
Epidemiologist. Writer (Guardian, Observer etc). "Well known research trouble-maker". PhDing at @UoW Host of @senscipod Email gidmk.healthnerd@gmail.com he/him
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This study is a common citation of ivermectin believers, has been reported widely, and I think is a great teaching tool in how little effort it takes to be critical about research findings 1/npic.twitter.com/YDZNB1JP5R
2/n The study is here, and has an objectively large impact with nearly a dozen news stories and an Altmetric of 2750https://www.medrxiv.org/content/10.1101/2021.05.31.21258081v1 …
3/n The study is pretty simple - 116 people with Covid-19, randomized to either receive ivermectin or a placebo Reported results were viral load, and more specifically proportion of people with Ct>30 at various time points on PCRpic.twitter.com/ozXyxZwAOj
4/n The authors report a marginally significant benefit at various days using an uncorrected logistic regression, and from this the massive attention sprangpic.twitter.com/5xk5vLDkrH
5/n One of the first things I do when I read randomized trials like this is look at their pre-registration. This is basically what the authors SAID they would do registered BEFORE they did it Here's the pre-reg for this trial:https://clinicaltrials.gov/ct2/show/NCT04429711?term=NCT04429711&draw=2&rank=1 …
6/n Immediately on looking at the pre-registration, there is a HUGE discrepancy with the published results Here's what the authors pre-registered as their exclusion and the flow chart from the study. Notice the difference?pic.twitter.com/eMFPtwG9Y6
7/n It appears that the authors have added an extra exclusion criteria that is applied AFTER randomization and treatment. This is "tested Ct>35" in the first two testspic.twitter.com/V5ZfCZWhv7
What would you say if the PI replace de study drug (yes, you heard it right) and still move forward with the trial?”
I've done this in a trial (the legislation changed and we had to update the medication) as long as you're open about the change and the reasons for it there should be no issue
In that case, since the drug changed (and is the one being investigated) wouldn’t you expect that sample size, safety endpoints etc would be obsolete?
Not necessarily. Depends on the situation, the drug etc. This is why openness is more important than anything for clinical trials
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