6 ms·

how do they find volunteers for such a trial? If I get it right, the risks are high (including death?) so seems like a big risk, and I suppose they need to star

how do they find volunteers for such a trial? If I get it right, the risks are high (including death?) so seems like a big risk, and I suppose they need to start with someone that's healthy to avoid confounding factors?

jedberg 6y ago
The risk of getting the virus is death too. If you're already in a risky position (say you're a teacher in a district that is insisting on in school teaching or a paramedic or cashier at a grocery store) then the vaccine trial might be the less risky option.
- dan_quixote 6y ago
  That's a terrific invitation for bias.
- djsumdog 6y ago
  Unless you're a teacher over the age of 55, your risk, even around a bunch of school children, is incredibly low (95% of fatalities in the US are over 55, with most of those being over 65). I've read a few of these "long term damage" studies that are scaring everyone. Of the 60+ people in the UK one published by the journal in Charlottesville, most of them were elderly or in "high risk" jobs (it didn't mention what jobs for privacy. Health care workers? grocery store? who knows).
- osivertsson 6y ago
  Getting COVID-19 now you would know the risk of death is very low, especially if you live in a society where you would have access to adequate intensive care. With the vaccine trial you are taking on an unknown risk which to me seems way worse. I think there are factors that drive people to join these trials though. For example if you have a loved one that has a much higher risk of severe complications if they catch the virus. Then it is in your interest to help get a vaccine ready.
  - Reason077 6y ago
    > "With the vaccine trial you are taking on an unknown risk which to me seems way worse." There's a reason why clinical trials are done in phases. If you are one of the very first to receive a new medicine or vaccine, then yes, you are taking a risk - and are compensated accordingly. By the time it gets to phase 3 trials, you already have a pretty good idea of the safety. One possible adverse event amongst 30,000 participants doesn't seem so bad to me. Certainly it's less than the risk of developing serious illness if you are infected with SARS-CoV-2.
    - FartyMcFarter 6y ago
      One adverse effect after X amount of time, hopefully this doesn't get any worse... :(
    - jimmydorry 6y ago
      That would be 11,000 people with quadriplegia or worse amongst a population of 330M. And keep in mind that the people participating in this trial are already pre-screened, taking the healthiest of the potential candidates. Known side effects would typically occur at higher frequency amongst the population than found in a clinical trial. EDIT: To add to this. The cost of rolling out medicine with SAEs at this rate would cost the company / government in the order of about $4,730,000,000 (430k x 11k) [1], which is about the equivalent to the amount paid out for all other vaccine caused injuries over the last 30 years. This is likely low-balling it though, as I bet the families sueing would get more than $430k with the numbers of eyes on this. [1] https://www.theatlantic.com/health/archive/2019/05/vaccine-safety-program/589354/ https://www.theatlantic.com/health/archive/2019/05/vaccine-s...
      - Reason077 6y ago
        My comment was in regard to the risks of clinical trial participation, not approved vaccines. There is some precedent for the scenario you describe, however: the 2009/10 H1N1 vaccine “Pandemrix” caused permanent narcolepsy in 1 in 55,000 children it was administered to: https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy
refurb 6y ago
The risk of death or serious injury with an investigational product is very low, but it does happen.[1] Clinical trials start after a lot of toxicology screening in vitro and then in animals. For first in human trials, the doses are sub-clinical and then dose-escalation studies are done to find out when adverse events start. They basically work their way up to therapeutic doses very slowly, monitoring the health of subjects very closely. [1]https://en.wikipedia.org/wiki/Theralizumab https://en.wikipedia.org/wiki/Theralizumab
klmadfejno 6y ago
I don't the answer to this either, but I was surprised at the scale (30,000 people!). It makes sense, but wow, sounds hard.
dahfizz 6y ago
> how do they find volunteers for such a trial? They pay them. Being a construction worker is another example of young, healthy people doing something dangerous and being compensated.
- ageitgey 6y ago
  The Oxford trial isn't paying anyone. I'm in the trial myself. I assume other people are volunteering because they want a COVID vaccine to come out. Volunteers for this trial range in age from 5 to 75+. Not everyone is perfectly healthy. People here are reacting like the vaccine isn't safe and is cancelled now. All this news means is that one person out of tens of thousands had a possible reaction and they have to investigate to see if it is even related to the vaccine (which is the proper procedure). This isn't even the first time that this has happened during this trial - it just wasn't reported so widely last time. The most likely outcome is they pause for a few days and then keep going as normal.
  - lbeltrame 6y ago
    Thanks for the context.
  - hestefisk 6y ago
    Thanks this is very helpful. I also just read in the Guardian that they paused it back in April due to a similar issue. Fingers crossed it resumes to plan.
  - anoncake 6y ago
    > Volunteers for this trial range in age from 5 I'm sure that 5-year old has carefully considered their decision.
animationwill 6y ago
I heard decades ago that prisoners will sometimes be recruited in exchange for reduced sentences, but not sure if that was the United States or elsewhere. Edit: I hope I am not spreading a myth further
- mbreese 6y ago
  That's something that is explicitly not done, unless there is a very good rationale for why it would need to be prisoners studied. The reason being, it is all but impossible for a prisoner to give a proper informed consent. There is just too large a conflict for testing to be considered voluntary, especially if there is some kind of quid pro quo. See here [0] for a list of permitted research on prisoners (45 CFR 46). True, it has been done in the past, but there are many... many horror stories associated with the practice [1]. [0] https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1306 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0... [1] https://en.wikipedia.org/wiki/Experimentation_on_prisoners https://en.wikipedia.org/wiki/Experimentation_on_prisoners

jedberg 6y ago

The risk of getting the virus is death too. If you're already in a risky position (say you're a teacher in a district that is insisting on in school teaching or a paramedic or cashier at a grocery store) then the vaccine trial might be the less risky option.

dan_quixote 6y ago
That's a terrific invitation for bias.
djsumdog 6y ago
Unless you're a teacher over the age of 55, your risk, even around a bunch of school children, is incredibly low (95% of fatalities in the US are over 55, with most of those being over 65). I've read a few of these "long term damage" studies that are scaring everyone. Of the 60+ people in the UK one published by the journal in Charlottesville, most of them were elderly or in "high risk" jobs (it didn't mention what jobs for privacy. Health care workers? grocery store? who knows).
osivertsson 6y ago
Getting COVID-19 now you would know the risk of death is very low, especially if you live in a society where you would have access to adequate intensive care. With the vaccine trial you are taking on an unknown risk which to me seems way worse. I think there are factors that drive people to join these trials though. For example if you have a loved one that has a much higher risk of severe complications if they catch the virus. Then it is in your interest to help get a vaccine ready.
- Reason077 6y ago
  > "With the vaccine trial you are taking on an unknown risk which to me seems way worse." There's a reason why clinical trials are done in phases. If you are one of the very first to receive a new medicine or vaccine, then yes, you are taking a risk - and are compensated accordingly. By the time it gets to phase 3 trials, you already have a pretty good idea of the safety. One possible adverse event amongst 30,000 participants doesn't seem so bad to me. Certainly it's less than the risk of developing serious illness if you are infected with SARS-CoV-2.
  - FartyMcFarter 6y ago
    One adverse effect after X amount of time, hopefully this doesn't get any worse... :(
  - jimmydorry 6y ago
    That would be 11,000 people with quadriplegia or worse amongst a population of 330M. And keep in mind that the people participating in this trial are already pre-screened, taking the healthiest of the potential candidates. Known side effects would typically occur at higher frequency amongst the population than found in a clinical trial. EDIT: To add to this. The cost of rolling out medicine with SAEs at this rate would cost the company / government in the order of about $4,730,000,000 (430k x 11k) [1], which is about the equivalent to the amount paid out for all other vaccine caused injuries over the last 30 years. This is likely low-balling it though, as I bet the families sueing would get more than $430k with the numbers of eyes on this. [1] https://www.theatlantic.com/health/archive/2019/05/vaccine-safety-program/589354/ https://www.theatlantic.com/health/archive/2019/05/vaccine-s...
    - Reason077 6y ago
      My comment was in regard to the risks of clinical trial participation, not approved vaccines. There is some precedent for the scenario you describe, however: the 2009/10 H1N1 vaccine “Pandemrix” caused permanent narcolepsy in 1 in 55,000 children it was administered to: https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy

refurb 6y ago

The risk of death or serious injury with an investigational product is very low, but it does happen.[1] Clinical trials start after a lot of toxicology screening in vitro and then in animals. For first in human trials, the doses are sub-clinical and then dose-escalation studies are done to find out when adverse events start. They basically work their way up to therapeutic doses very slowly, monitoring the health of subjects very closely. [1]https://en.wikipedia.org/wiki/Theralizumab https://en.wikipedia.org/wiki/Theralizumab

klmadfejno 6y ago

I don't the answer to this either, but I was surprised at the scale (30,000 people!). It makes sense, but wow, sounds hard.

dahfizz 6y ago

> how do they find volunteers for such a trial? They pay them. Being a construction worker is another example of young, healthy people doing something dangerous and being compensated.

ageitgey 6y ago
The Oxford trial isn't paying anyone. I'm in the trial myself. I assume other people are volunteering because they want a COVID vaccine to come out. Volunteers for this trial range in age from 5 to 75+. Not everyone is perfectly healthy. People here are reacting like the vaccine isn't safe and is cancelled now. All this news means is that one person out of tens of thousands had a possible reaction and they have to investigate to see if it is even related to the vaccine (which is the proper procedure). This isn't even the first time that this has happened during this trial - it just wasn't reported so widely last time. The most likely outcome is they pause for a few days and then keep going as normal.
- lbeltrame 6y ago
  Thanks for the context.
- hestefisk 6y ago
  Thanks this is very helpful. I also just read in the Guardian that they paused it back in April due to a similar issue. Fingers crossed it resumes to plan.
- anoncake 6y ago
  > Volunteers for this trial range in age from 5 I'm sure that 5-year old has carefully considered their decision.

animationwill 6y ago

I heard decades ago that prisoners will sometimes be recruited in exchange for reduced sentences, but not sure if that was the United States or elsewhere. Edit: I hope I am not spreading a myth further

mbreese 6y ago
That's something that is explicitly not done, unless there is a very good rationale for why it would need to be prisoners studied. The reason being, it is all but impossible for a prisoner to give a proper informed consent. There is just too large a conflict for testing to be considered voluntary, especially if there is some kind of quid pro quo. See here [0] for a list of permitted research on prisoners (45 CFR 46). True, it has been done in the past, but there are many... many horror stories associated with the practice [1]. [0] https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1306 https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0... [1] https://en.wikipedia.org/wiki/Experimentation_on_prisoners https://en.wikipedia.org/wiki/Experimentation_on_prisoners