Hardcore!
Now THAT is what I call a controlled experiment.
None of your namby pamby "How did you feel about the injection? Did it hurt? What colour syringe did you think would be best?"
Nope.
"Here's a faceful of Covid."
Bosh.
Now THAT is what I call a controlled experiment.
None of your namby pamby "How did you feel about the injection? Did it hurt? What colour syringe did you think would be best?"
Nope.
"Here's a faceful of Covid."
Bosh.
Remind me NEVER to mock millennials again.
While some people "do their bit" by setting up a Facebook page to encourage people to feel ill, these people do something that puts a new meaning to the term "service to humanity".
Awesome.
While some people "do their bit" by setting up a Facebook page to encourage people to feel ill, these people do something that puts a new meaning to the term "service to humanity".
Awesome.
Source is pay walled but please anyone add a link if you can find a public source.
UK to host world’s first human challenge trials for Covid-19 - on.ft.com/3kJVELo via @FT
UK to host world’s first human challenge trials for Covid-19 - on.ft.com/3kJVELo via @FT
There's always someone who can't believe there are courageous people out there who actually try to help others.
The reason those brave youngsters are doing this is same reason we normal people in general wear face coverings even though we are free not to.
Some people are more altruistic than you and me.
Get over it.
Get over it.
I see there's still people trying to peddle made-up fears, as if the real fears aren't bad enough.
Fortunately the voices of reason are growing!
Fortunately the voices of reason are growing!
Thank you for the non paywalled link!
https://twitter.com/stevethefarm/status/1308842885035556869?s=19
It's not for everyone.
Only courageous altruistic people need apply. Obviously they only take people at very low risk of actually dying.
Yet still something like a 50 50 risk of getting symptoms.
And you know the worst thing about this trial?
Only courageous altruistic people need apply. Obviously they only take people at very low risk of actually dying.
Yet still something like a 50 50 risk of getting symptoms.
And you know the worst thing about this trial?
Enrolling doesn't even get you somebody to pay your resulting medical bills...
Cos we all pay each other's medical bills anyway!
National
Health
Service
So it is pure altruism.
These young volunteers are the real heroes of the UK.
They see duty where you and I see terror.
Cos we all pay each other's medical bills anyway!
National
Health
Service
So it is pure altruism.
These young volunteers are the real heroes of the UK.
They see duty where you and I see terror.
In a world where we are awed by resolution of video displays, or speed of 2 hour grocery delivery, it is good to be in awe now and again of something truly heroic and altruistic.
Yes, I am in awe of those who volunteer.
Yes, I am in awe of those who volunteer.
You don't have to wonder this.
In the UK and several other European countries, we all pick up the tab for each other.
It's sounds a little communistical to American ears, I accept, but it works for us.
It's sounds a little communistical to American ears, I accept, but it works for us.
A thoughtful and heartfelt message, but i disagree.
https://twitter.com/AlexLickerman/status/1308902422484582405?s=19
... because we do trials that have small risks of death all the time.
That's the source of the confident information behind modern medicine.
Doesn't come from a great knowledge spout in the sky.
It's real people, volunteering.
That's the source of the confident information behind modern medicine.
Doesn't come from a great knowledge spout in the sky.
It's real people, volunteering.
You seem very confident 8-)
Whom would you randomize?
What outcomes would you measure?
What sample size would you go for?
And therefore when would you get the result?
Whom would you randomize?
What outcomes would you measure?
What sample size would you go for?
And therefore when would you get the result?
It is questions like these that clinical researchers have to think about all the time.
We will shortly be showing an interview with Milton Packer who talks about this for Heart Failure trials. Young medics interested in clinical research might enjoy it.
We will shortly be showing an interview with Milton Packer who talks about this for Heart Failure trials. Young medics interested in clinical research might enjoy it.
For readers in the UK:
"Imagine having to worry about paying for healthcare or medical bills."
(Next time you complain about having to pay tax, or things being a bit pricey compared to in USA.)
"Imagine having to worry about paying for healthcare or medical bills."
(Next time you complain about having to pay tax, or things being a bit pricey compared to in USA.)
If you randomize people between vaccine and placebo, and send them out on their merry way, catching covid the natural way...
... then instead of being HAPPY about a resolving pandemic, you are miserable, because:
What would be your endpoint?
Which outcome would need the largest trial, and why?
Choosing the thing that happens fewest-ly, i.e. death, causes you to require the largest trial.
This means
This means
So nobody (in their right mind) is using that endpoint.
Hospitalization is more frequent, so could get away with a smaller trial (perhaps with no actual deaths, which is always nice)
Symptoms are EVEN MORE frequent, so "symptoms confirmed by test" could be an efficient target.
Hospitalization is more frequent, so could get away with a smaller trial (perhaps with no actual deaths, which is always nice)
Symptoms are EVEN MORE frequent, so "symptoms confirmed by test" could be an efficient target.
Even more frequent than SYMPTOMS is INFECTIONS, since (about) half of people are asymptomatic.
That would require the smallest number of volunteers (so massively less money, time, and people).
That would require the smallest number of volunteers (so massively less money, time, and people).
But how do you *document* infections.
Got to keep testing them. Over and over and over.
Annoying for participants and, itself, is expensive and demanding on staff time.
Got to keep testing them. Over and over and over.
Annoying for participants and, itself, is expensive and demanding on staff time.
Good question:
I haven't checked what they are using, but I doubt they would go for a thing like "disease" because
(a) it is unclear whether an asymptomatic infection would count, and
(b) they presumably want to get some kind of continuous variable out of each participant, e.g. PCR titre.
(a) it is unclear whether an asymptomatic infection would count, and
(b) they presumably want to get some kind of continuous variable out of each participant, e.g. PCR titre.
Yes! This is a very real risk.
Clinical Researchers have to trade off these risks all the time.
Anyone interested in this sort of question, e.g. baby cardiologists thinking of a career of research, do come and visit us at CVCT Cardiobrief where we discuss such trade-offs with trial PI's.
Milton Packer next!
Anyone interested in this sort of question, e.g. baby cardiologists thinking of a career of research, do come and visit us at CVCT Cardiobrief where we discuss such trade-offs with trial PI's.
Milton Packer next!
It's not automatically unethical to conduct a trial with a mortality endpoint.
We do this all the time with heart failure trials, for example.
That's how we have found so many useful interventions (and discarded so many useless or harmful ones).
We do this all the time with heart failure trials, for example.
That's how we have found so many useful interventions (and discarded so many useless or harmful ones).
https://twitter.com/doctorocky/status/1309153181130264586?s=20
So I do not discount mortality on the grounds of unethical-ness.
I discount it on grounds of impracticability. The number of patients needing to be recruited, if they are young and fit, is too vast.
I discount it on grounds of impracticability. The number of patients needing to be recruited, if they are young and fit, is too vast.
I think they will go for something at the other end of the spectrum, as time is of the essence.
This consideration of how to design a trial is what I find most fascinating.
This consideration of how to design a trial is what I find most fascinating.
Too often I see inane criticisms of trials, from people who have no insight into the design process. It's quite funny.
I remember someone said, "ORBITA should have had a 3rd arm, where you told people that they had a stent, but in fact you didn't put one in."
When I probed him more about this, I realised it was just a random half=witted interjection, with no neurons utilised behind it.
<sigh>
When I probed him more about this, I realised it was just a random half=witted interjection, with no neurons utilised behind it.
<sigh>
Great question here!
In study A, we bring in patients and expose them all to Covid, and measure their viral load, antibodies, blah blah, whatever we want, every day for 2 weeks.
We calculate that we need (say) 20 people to do the study adequately.
We calculate that we need (say) 20 people to do the study adequately.
Now imagine Study B, where we instead let the volunteers, after vaccination, go out and face Covid naturally.
How many volunteers will we need?
How many volunteers will we need?
Suppose only 10% actually come into contact with Covid.
Clearly we need 10 times as many volunteers.
Clearly we need 10 times as many volunteers.
But wait, it's worse than that.
What kind of people preferentially volunteer for medical research?
What kind of people preferentially volunteer for medical research?
And will such people tend to follow public health guidelines
Think about the effect on their chances of catching Covid naturally.
In turn, how many people will we need in study B?
In turn, how many people will we need in study B?
Incidentally that is why all trials of a disease always recruit people at a lower event rate than the observational studies of the disease.
And clinical trialists have to think about this when designing their trials and sample sizes.
And clinical trialists have to think about this when designing their trials and sample sizes.
Next problem.
In study A we did daily assessments for a couple of weeks after we Covid'd them.
In study B, how do we do the daily assessments?
In study A we did daily assessments for a couple of weeks after we Covid'd them.
In study B, how do we do the daily assessments?
And now the worst problem.
In study A, the results are available 2 weeks (or whatever) after we begin.
In study B, when are the results available?
In study A, the results are available 2 weeks (or whatever) after we begin.
In study B, when are the results available?
So approach B, "expose naturally", sounds less harsh, *but*
* Will take 10-20 times more volunteers at least
* Will cost much more PER VOLUNTEER PER DAY
* Must run for more days since exposure may take ages
* Will run for much, much longer
Vastly more $ and time to answer.
* Will take 10-20 times more volunteers at least
* Will cost much more PER VOLUNTEER PER DAY
* Must run for more days since exposure may take ages
* Will run for much, much longer
Vastly more $ and time to answer.
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