61 points by toomuchtodo 3 days ago | 5 comments
_heimdall 1 hour ago
Unless I'm reading the original study [1] wrong, I'm surprised the study only used a population size of 28.

They did do a 12 month check-in which is good, but why such a small group of study participants, especially when malaria is so widespread?

[1] https://clinicaltrials.gov/study/NCT04300309?term=CALINA&ran...

BugsJustFindMe 1 hour ago
Ethics dictate always using the smallest viable cohort to show that giving the treatment regimen (in this case dosage for a drug known to be effective) isn't obviously worse than the thing it's supposed to treat, even if we're already pretty sure. This also keeps the costs of running the studies down so we can effectively conduct more studies for more treatments.

We also already have data about its use in babies over 11 lbs, and this is just going even smaller to 4.4 lbs, so a strong baseline has already been demonstrated.

freeone3000 1 hour ago
Statistical power. Malaria doesn’t go away on its own. They know the treatment should be overwhelmingly effective if dosed correctly, it’s merely a measure of determining dosage vs negative effects.
_heimdall 1 hour ago
Also they apparently didn't use a control group, the study was terminated early, and after the 43 day test window 9 of the 28 participants are listed as having the adverse event of malaria.

I'm particularly confused by that last one. How is malaria considered an adverse event when testing an anti-malaria treatment? Other data in the study shows that 1 participant had malaria again with matching DNA, meaning the original infection likely came back. 6 others were reported as getting malaria again but with different DNA. So what does it mean to have 9 with the adverse event of malaria?

6 minutes ago
2 hours ago
toomuchtodo 3 days ago
frogarden 5 hours ago
Good news! How do you safely develop medications for babies?
lamuswawir 2 hours ago
This particular one is mostly about dosing, the available medicines were weight based, with lowest dosages in the 5-15kg range. This brings dosages lower allowing more precise dosing for the lighter babies.

Edit: it's a very welcome addition. Limits side effects.

zkmon 4 hours ago
Approved for use means approved for testing on populations.
1over137 1 hour ago
As opposed to what?
parpfish 1 hour ago
Probably as opposed to “approved for general use in the population because we’ve passed all of our tests”, which is what I’d assume “approved for use” means
squigz 3 hours ago
Isn't that how medicine works?
zkmon 1 hour ago
Only for lab mice. Humans require making it clear that they are not being used as lab mice. But often, you see report saying that "After seeing the results for x years of use by populations, we found that it has y side effect which was not known earlier". A doctor literally said this to me last week.
Calavar 1 hour ago
What alternative process do you propose that will discover all side effects, including those with well under 1% occurence, without human use?