Well, I don’t know how a trial of this sort would work (would it fall under medical device regs? I’d assume so). But in pharmaceuticals, you start with healthy volunteers. So if that’s the case here, the question stands.
(incidentally, I’m not in devices, but the regs over there are messed up- basically, you can continually evolve a device, riding on a past approval, until your ultrasound machine is a PET-CT scanner)
Edit: I think I’m misunderstanding something you’re saying, given your experience in the field. My apologies for my tone; please understand that I’m trying to understand what you’re saying.
I worked for a short stint in a clinical research facility, and they didn’t test pharmaceuticals on healthy folks, because that would be unethical. They tested treatments on folks who stand to benefit from the treatment if it works properly. The only time you’d test on healthy folks is if you’re testing a vaccine or other preventative pharmaceutical.
In fact, the ethical standard is even higher than that. You have to convince the Institutional Review Board that your treatment has a good chance of being better than the best treatment currently available. If you have a new chemotherapy cocktail, and there’s currently a cocktail in use, you need to show that yours is likely either to be more effective, or have fewer side effects, in a particular cohort of patients. If you can’t do that, your study will be denied.
The general approach is as follows. There are sometimes other ways, and it matters whether the study drug is (say) a diagnostic or a therapeutic.
Phase 1: Healthy volunteers. You want to see that the drug is well tolerated. You don’t want the confounding factor of sick people (75% of our stage 4 cancer patients died. Is it because of the drug or the cancer?). You want to check safety and get some sense of dosing, at what amount of drug you see pharmacalogic effects, side effects, etc. Phase 1, to my experience, is always open label (again, you might find some oddballs out there)
Phase 2 is where you start looking at the impact on the disease state. Here is also where you may look at cohorts to determine how much is the right amount. You’re continuing to establish safety. Generally P1 and P2 can be quite small, but again, the statisticians have to determine how many people you need (true for all phases). If you have an illness terminal 100% of the time, the number of subjects to show effectiveness of the drug will be smaller. If you want to add 6 months life to a chronic illness people live with for two decades, you’ll need a fuckton of people; I am NOT a statistician so take that as an overview of the idea, not an actual example)
Phase 3 is where you prove that this drug, administered according to this label, has the intended effect. Ideally it’s double-blind and includes a placebo. But again, that’s not always possible (you are never going to give someone a radioactive placebo, for instance, and if you remove the radioactivity to make the placebo, everyone will know it’s the placebo). The study will have defined endpoints that establish what is a success in advance.
IRBs really just make sure that a study is in alignment with the institution’s safety standards and protocols. They can ask for some changes (like, I want the subjects to have their blood pressure checked prior to enrollment) but they DO NOT define the study. They can, of course, decline to allow participation.
Broad overview. Lots of exceptions. Different areas of pharma operate differently (ie, therapeutic vs diagnostic). I’ve even seen where a diagnostic was brought to market without a trial. In that case, it had been studied academically for years and someone was able to collate all that data and submit- but that’s not normal.
Y’know what? Thinking back on it, I believe that all the trials I was helping with (secretarially, not trying to give myself any expert credentials here) were phase II and III, since the clinical research center was part of a hospital. That’s probably where I got confused. Thank you for the education!
I wouldn’t put it past him. You’ll know when that’s his new strategy when he acquires a bunch of horses for payouts.
Twitter admits that it’s blocking Ukraine from using Skylink to run their offensive drones.
Please enjoy this detailed cataloging of Musk’s incomparable technology management skills.
comedy gold, right there:
“If Elon can learn how to put a bit more thought into some of the decisions, and fire from the hip a bit less, it might do some good,” the employee said. “He needs to learn the areas where he just does not know things and let those that do know take over.”
At the same time, “he really doesn’t like to believe that there is anything in technology that he doesn’t know, and that’s frustrating,” the employee said. “You can’t be the smartest person in the room about everything, all the time.”
With Musk continuing to fire people impulsively, entire teams have been wiped out, and their work is being handed to other, overstretched teams that often have little understanding of the new work that is being assigned to them.
“They have to become code archaeologists to dig through the repo and figure out what’s going on,” one employee said."
Thank you. That article was hilarious! 
Or in his case seemingly even some of the time.
Or sometimes, seemingly, any of the time.
Hehehe, the cause for the outage yesterday is my favorite part:
Just the chaff leaving, huh?
The people responsible for firing the person responsible have been fired.
As long as the firers were fired before the firee we have a net benefit: the firee remains on the job.
This is a bit of a hijack, so I won’t continue after this comment.
I did a number of phase 1 clinical trials in the UK in my youth, because I was healthy and wanted the fairly substantial money offered.
Every single one was in a hospital, in a specialised ward with 24/7 supervision by several experienced nurses, and doctors on call.
In one of them, the lead doctor told us “guinea pigs” that they had spent X million pounds in researching and creating the pharmaceutical, so they were pretty certain it would be OK for phase 1 (first time in humans)
On the other hand, I did one in Scotland - again in a hospital - where when chatting with the nurse on duty, she told me about some people in a previous Stage 1 trial going into a medical emergency situation when testing fenatyl… at that stage I only knew of it from the response of the Russian mass gassing of the Dubrovka Theater, in which Chechen rebels were holding hostages.
That did not work out well for the hostages.
Anyway, the point being, almost all clinical trials are carried out in a hospital, because they really, really don’t want someone to die. Imagine if you read the small print on the medication you are prescribed and in the uncommon side-effects section, just after tinnutis and loss of appetite, there comes the words “risk of death”?
or … even if alone in the room … 
I’m sure the advertisers are going to be thrilled about this. Everybody loves holocaust deniers a.k.a. Nazis.
Ok, that made me laugh a lot. Nicely done!
“Down here, we aim to please”
The words “sad” and “pathetic” come to mind. Also the words “Haw! Haw!”.