3 ms·
While a control group is essential to determine if the effect is really due to the treatment or to practice, if they did the mouse study first and expected a po
by jinto36 5y ago
While a control group is essential to determine if the effect is really due to the treatment or to practice, if they did the mouse study first and expected a positive effect, then they might have felt pressure to only have a human treatment group in what looks like a pilot trial. Maybe their original proposal included a control group, but their institutional review board decided against it?
I'm a little surprised they wouldn't have done a larger secondary trial before publishing, the impact would have been much greater if the effect was still observed in a larger group, even if they still did not have a control group- or perhaps had an alternative treatment schedule (shorter exposure times- is treatment duration correlated with degree of improvement? Then you have less of a moral dilemma of denying participants of a useful treatment while still getting some data that would indicate the treatment itself actually does something).
(working on a PhD in genetics)
- simiones 5y agoI am not a practitioner, so I have no idea if this is actually plausible, but it would seem absurd to me for an experimental, out-of-left-field treatment for Alzheimers, in a <10 person study, could be denied a control group on ethical grounds. There are tens if not hundreds of millions of Alzheimer's patients not receiving this potential treatment already.
- lthornberry 5y agoThis. There is basically zero chance that an ethics review would see this as a case in which a control group is unethical. I have been through plenty of IRB processes. Resource constraints are a much more plausible explanation - running the study with a control group would cost twice as much (in time as well as money). This is either a pilot to apply for funding to run a better-controlled trial, or it's just not scientifically serious. Both are very plausible, in my experience.
- jinto36 5y agoThanks for the perspective, I have only done data analysis after the data is generated, and never have actually had to deal with an IRB directly for the design of a study.
- parliowl 5y agoI don’t want to speculate about why they designed their study this way or that way, because who knows. I do feel confident in saying that Scientifically, the human data in this study are largely uninformative.
- reacweb 5y agoYes control group is very important. This link might interest you https://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/?fbclid=IwAR3mWDWkCcTwVyrOuUOAcpPF_YH7Xwk8duuyI1qIiduZ4I7E6m0OJyNyJck https://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/?fbclid=...