I just enrolled as a volunteer for a Covid-19 vaccine study

Via an online registry.  

 

I just volunteered to be in a Covid-19 study. 

I may or may not be selected for a study for various reasons including:

 - I don't meet their criteria (some personal and health questions were part of the registry).

 - There may not be a study/trial occurring in my area. (Local news spots were encouraging folks to volunteer.)

 

I may or may not be contacted at all.  

I may or may not be contacted later if new studies/trials are opened in my area.

 

So far just an online volunteer, no further information.  If contacted I would be further interviewed, more details explained, could continue or withdraw.

 

These facts were given: 

 - Participants will NOT be exposed to Covid 19 as part of the study.

 - If selected I would either receive a vaccine or a placebo, would not know which.

 - Participation means checking in (someplace) at least 10 times over 2 years for followup.  Possibly some blood testing.

 - No financial or insurance information will ever be asked.  No mention of $ compensation for enrollment.

 

Just thought this might be of interest.  

 

Candy

Edited on Nov 13, 2020 9:27am

I checked this out in my area as well. However, they told me that they were already oversubscribed! Not that they wouldn't welcome as many data points as possible, but they only had so much capacity for followup, blood work to evaluate, etc. Like you, I was told that I might not meet their criteria for inclusion, but it didn't get that far at this time anyway.

 

I'm wondering---how exactly is it proved that a vaccine is effective? You can't deliberately expose vaccinated people to Covid! And yes, you supposedly develop antibodies, but are those antibodies "combat-tested," as in, has anyone with antibodies spent a weekend at a biker rally, beach party, Trump rally, etc.?

 

My greatest concern is even if this or another vaccine proves effective and becomes widely available, how many moronic brain-dead superstitious conspiracy theory-swallowing drooling wingnuts will refuse to get vaccinated---and/or refuse to have their children vaccinated? We socialist commies would advocate a stiff criminal penalty for refusing to be vaccinated--but we won't have that here, because, y'know, FREEDUMB.

Thanks, Kevin.  I hope I get in, though possibly I would get the placebo and not the vaccine.  At least I'd have a 50/50 chance of getting a reasonably proven vaccine before it is widely available to everyone. 

 

Candy

My understanding--and I'll gladly admit this is wildly outside of my field--is that people receive either the vaccine or a placebo and then go about their lives.  Cases within this universe--both groups--are monitored.  Then when a previously predetermined number of actives cases are detected in the universe (50, 100, etc,)  they examine the data to see if most of those cases (by %) are in the control group as related to the number of cases in the experimental group.   The fewer (%) of the cases in the experimental group, the more effective is the vaccine.  For example, if 90% of the cases were in the control group, I guess that makes the vaccine 90% effective.  The study continues trough a number of case levels to reinforce the original conclusion, and to to continue to test for side effects.  Please correct my understanding if this is incorrect--I welcome it.


Sounds about right Dealer 1.  They really do need a lot of studies to get a handle on things.  Like proving a negative, is it?

Originally posted by: Dealer1

My understanding--and I'll gladly admit this is wildly outside of my field--is that people receive either the vaccine or a placebo and then go about their lives.  Cases within this universe--both groups--are monitored.  Then when a previously predetermined number of actives cases are detected in the universe (50, 100, etc,)  they examine the data to see if most of those cases (by %) are in the control group as related to the number of cases in the experimental group.   The fewer (%) of the cases in the experimental group, the more effective is the vaccine.  For example, if 90% of the cases were in the control group, I guess that makes the vaccine 90% effective.  The study continues trough a number of case levels to reinforce the original conclusion, and to to continue to test for side effects.  Please correct my understanding if this is incorrect--I welcome it.


I get that, but how can they control for all the variables involved---we know that even within a given community, the amount and frequency of any one person's exposure varies wildly. So if someone in the vaccine (not control) group tests positive, is it because the vaccine was ineffective or because they were subjected to an intense viral load?

 

I'm sure there are metrics for figuring all this stuff out, and we sophisticated gambler types (ha!) know that the way to "smooth out" data is to have as large a number of data points as possible. I do strongly suspect that a major component of the research is actually seeing if people who get the vaccine get sick or croak because of the vaccine---and if that number is small enough, we can pass out the vaccine like Halloween candy even if it's only 50% effective or less---the way we've done with many flu vaccines.

Originally posted by: O2bnVegas

Thanks, Kevin.  I hope I get in, though possibly I would get the placebo and not the vaccine.  At least I'd have a 50/50 chance of getting a reasonably proven vaccine before it is widely available to everyone. 

 

Candy


It's my understanding that these are double-blind trials, meaning that not only do you not know if you're getting the vaccine or the placebo, the people giving it to you don't know either.

Originally posted by: Kevin Lewis

It's my understanding that these are double-blind trials, meaning that not only do you not know if you're getting the vaccine or the placebo, the people giving it to you don't know either.


Yes. And the selection of participants and whether they are in the vaccine or placebo cohorts is randomized. Then the results are put through best practices statistical analysis to determine the efficacy and confidence level in the results.

 

I just want to point out that if chloroquine had succeeded at this kind of a trial, the twits that advocated for it would still be twits. It's this process that makes it science, not the results.

If you want to read an entertaining article about someone in the Pfizer trial:

 

I Am Not a Brave Person. I Am Also Patient 1133.

Edited on Nov 13, 2020 1:32pm
Originally posted by: Kevin Lewis

It's my understanding that these are double-blind trials, meaning that not only do you not know if you're getting the vaccine or the placebo, the people giving it to you don't know either.


Should be double-blind.  Not sure about randomizing.  Probably depends on the study, but can I and my generally healthier social group be randomized along with those in nursing homes or prisons or people with 4 kids coming home from school?  Maybe.  Research is tricky.   

 

Randomized double-blind placebo controlled is said to be the gold standard of research.

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