We even have a rule about it! The name of which I cannot remember right now. But basically it says if there is a chance for harm to a test subject, you need to design your testing to prevent that shit, like death!
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There have also been cases where placebo-controlled tests get shut down early because the results show the tested drug is so clearly effective that it would be unethical not to give it to the placebo group as well.
Even before you get to IRB review, FDA can (should) reject an IND or IDE application if the proposed research will result in death, injury requiring hospitalization or congenital anomaly
Unless some ignorant DOGE bro cuts it because it looked too burdensome. Even as it stands, it's remarkable how flexible an IRB can be in determining that risk to subjects are minimized and that risk is reasonable in relation to anticipated benefit.
So the next time your, I do my own research shithead says I don’t see anything wrong with what Lowly’s human car wants to do. Fucking punch them in the arm and ask if they want an aspirin or a skittle. Mother fucking dumb ass bitches!!!
I will literally sign up for any demonstration, talk, or seminar @altfda.altgov.info is giving. This is how motherfucking science should be explained punk ass bitches1
Novavax: how do you measure efficacy of a vaccine when there's low levels of infection in the community? What if nobody in the placebo arm gets infected during the trial? You can't do a challenge study because there's no treatment for covid, unlike say, vivax malaria.
There’s no scientifically valid reason to do this, as far as I understand it. Placebo studies are useful in some cases (painkillers and antidepressants are great examples where there is a strong placebo effect), but that is not the case for infectious disease and vaccines.
You can also do challenge studies using animals susceptible to disease. If you’re just tweaking something that already works (like flu or COVID vaccines), either approach is resource intensive for little new information.
Precisely. So why is FDA commish doubling down on demanding a new RCT from Novavax?
We have an MOU with Health Canada, where Novavax is approved. The whole thing is nuts.
Animal challenge studies got the anthrax vaccine approved IIRC.
I’m guessing (1) sow doubt with general public that testing isn’t being done in a scientifically valid way. People know about RCTs and placebos but not the more inside baseball details of trials and (2) generate datasets showing large numbers of side effects “vs placebo” that sound bad.
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https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56
Even before you get to IRB review, FDA can (should) reject an IND or IDE application if the proposed research will result in death, injury requiring hospitalization or congenital anomaly
#skittlebitches
We have an MOU with Health Canada, where Novavax is approved. The whole thing is nuts.
Animal challenge studies got the anthrax vaccine approved IIRC.
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