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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 ob

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.

verisimi 1y ago
a small study.... that then gets approved and released to everyone!
- refulgentis 1y ago
  A little dull assertion can't hurt you, individually, and I bet it feels fun. I assume you're well-aware the process for something like this doesn't fit in a sentence. Additionally, there's context in the comment you're replying to, this isn't the only study.
_heimdall 1y ago
What do you mean "ethics dictates?" We define ethics and they generally reflect the current culture, ethics aren't universal and can't dictate anything. The scientific method, though, would dictate that a cohort size should be large enough to show a high probability of safety and efficacy, assuming that is what is being tested. It would also dictate that a control group would be needed to compare against the test group. I totally understand the ethical concerns of potentially allowing children to be harmed while part of a control group, but when the test is being done specifically because there is currently no treatment the only change is that they would pick a group of untreated children that are a valid control group for the study. Either way those children wouldn't be treated and there really isn't an ethical issue to deal with.
- roywiggins 1y ago
  There is a treatment, but it's done ad-hoc: > Until now there have been no approved malaria drugs specifically for babies. > Instead they have been treated with versions formulated for older children which presents a risk of overdose.
  - _heimdall 1y ago
    The claim still holds then that there are no approved treatments for malaria in this age range. If we were already treating patients off book, and that were the reason we couldn't have a control group, then there is no real reason to do the study at all.
- longfingers 1y ago
  Having a control group in a life saving intervention study is a major ethical dilemma that isn't as simple as they would die if not in the study.. There's a lot of information about study ethics and it is more complex a subject than you imply.
  - _heimdall 1y ago
    Is it in this case though? The study, and the related article, states that there is currently no approved treatment for the population. What is the harm in following a control group that would otherwise still go untreated?

verisimi 1y ago

a small study.... that then gets approved and released to everyone!

refulgentis 1y ago
A little dull assertion can't hurt you, individually, and I bet it feels fun. I assume you're well-aware the process for something like this doesn't fit in a sentence. Additionally, there's context in the comment you're replying to, this isn't the only study.

_heimdall 1y ago

What do you mean "ethics dictates?" We define ethics and they generally reflect the current culture, ethics aren't universal and can't dictate anything. The scientific method, though, would dictate that a cohort size should be large enough to show a high probability of safety and efficacy, assuming that is what is being tested. It would also dictate that a control group would be needed to compare against the test group. I totally understand the ethical concerns of potentially allowing children to be harmed while part of a control group, but when the test is being done specifically because there is currently no treatment the only change is that they would pick a group of untreated children that are a valid control group for the study. Either way those children wouldn't be treated and there really isn't an ethical issue to deal with.

roywiggins 1y ago
There is a treatment, but it's done ad-hoc: > Until now there have been no approved malaria drugs specifically for babies. > Instead they have been treated with versions formulated for older children which presents a risk of overdose.
- _heimdall 1y ago
  The claim still holds then that there are no approved treatments for malaria in this age range. If we were already treating patients off book, and that were the reason we couldn't have a control group, then there is no real reason to do the study at all.
longfingers 1y ago
Having a control group in a life saving intervention study is a major ethical dilemma that isn't as simple as they would die if not in the study.. There's a lot of information about study ethics and it is more complex a subject than you imply.
- _heimdall 1y ago
  Is it in this case though? The study, and the related article, states that there is currently no approved treatment for the population. What is the harm in following a control group that would otherwise still go untreated?