[sandworm101]

There is an additional question that opens the door to all sorts of hidden exclusions: Were study participants given medical advice prior to participation?

If I ask my doctor whether it is a "good idea" for me to participate in an investigational study like this, there are all number of reasons he may advise against. Those reasons form a defacto hidden list of exclusions. Would a doctor advise a patient with diabetes, high blood pressure, or any other chronic illness, to participate in such a study?

[Emphere]

Why wonder? You can read in the original press release that there were ~5000 patients under the age of 65 with chronic diseases such as diabetes, severe obesity and cardiac disease. There were also ~7000 patients over the age of 65. That seems reasonable to me.

[yibg]

Isn't this why the results are compared against the control group?

[sandworm101]

For a study to be valid and useful, the control group has to go through exactly the same criteria as the test group. Everyone is "blind" to whether they get the placebo or the real thing. So they all get the same interviews/tests and rejection criteria. Putting all the diabetics in the control/placebo group would make it pretty obvious who was and wasn't getting the real thing.

[jrochkind1]

Not every single study is blinded -- sometimes there are ethical reasons that lead against it. And you can have a valid study without it sometimes.

But looking up this one, it was blinded, indeed! https://www.henryford.com/moderna-vaccine/faqs

Even if it isn't blinded, you try to make sure the control group and experimental group are equally representative though, you don't "put all the X in the Y group" ever, this is true! Because the whole point is testing two groups as much alike as possible other than the thing you are testing.

[justinc8687]

As someone who volunteered for the AZD12222 trial and who has various "co-morbidities", I consulted with 2 of my doctors beforehand. Given that none of the vaccines being tested are live virus vaccines (meaning there is 100% no way to get COVID-19 from the vaccine, unlike say, the polio vaccine), and all had already passed Phase 1 safety trials, they both put it as (paraphrasing): "It's a personal choice, but if you do it, thank you for helping science."

I think COVID-19 is perhaps different than many other types of diseases in it's mainly-selective dangerousness to select groups of people. A healthy 30-something is unlikely (but possibly) to have severe, hospital-landing COVID. Someone with various co-morbidities, however is more than twice as likely to die than someone without. As such, I think that makes it much more likely that this group will volunteer, than "normal" people. It's certainly what drove me to do so.

The only issue they seemed to really care about during the intake was immunosuppression. As another comment pointed out, as long as other medical conditions were stable, you were eligible. From the vaccine makers point of view, I'd surmise this group is almost desired (my personal opinion), as you're less likely to a have asymptomatic COVID infection, which given how they are running the trial are unlikely to get noticed.

I take great solace in hearing that among the people who got COVID even when having received the vaccine (I'm talking about the AstraZeneca one, which is ~70% effective), there were no serious cases that required hospitalization. This indicates that even among the "not-effective" group, the vaccine confers some immunity. For me, that bring the personal risk factor from "possible death sentence" to "just like the flu...it'll suck for 2 weeks but I'll be fine".

Obviously I don't know if I got the vaccine or not (though given I felt crappy the next day, I'm fairly sure I did), which as another commenter points out is what makes these trials effective. Neither I, nor the doctors I met with (nor anyone at the clinic where I received it) has any idea if I got vaccine or placebo. In fact, they even had the vaccine couriered over from another hospital pharmacy using only a numeric identifier so really nobody knows what I got.

Coming back to the original question, I think many people, especially with co-morbities might seek out advice before enrolling, but at least in my case, two doctors were all for it.

I'm thankful I enrolled, and I'd encourage others, especially those who are more likely to get severe COVID to do so as well!

[amanaplanacanal]

Why wouldn’t they? It’s not like the study intentionally infected people with the virus.

[sandworm101]

Because the default with chronically ill patients is no. There are also financial issues. If a patient is chronic then they are likely on ongoing treatments of some sort. If complication arise from the investigational medication then questions come up as to who will pay for what treatment. What if the complications lead to the patient having to abandon the ongoing chronic treatment? So the docs will lean towards no. And in the US there is the huge question of whether one's insurance even allows for such participation, but that is a question for one's lawyer rather than doctor. All such concerns can lead to the exclusion of certain populations, possibly the populations more relevant to the study.