3 ms·

1) BMJ is rabble-rousing. Endpoints for any pivotal trial will be agreed with regulators in advance. In this case, while I don’t know the numbers themselves, I

by mft_ 6y ago

1) BMJ is rabble-rousing. Endpoints for any pivotal trial will be agreed with regulators in advance. In this case, while I don’t know the numbers themselves, I suspect that given the low rate of serious complications of Covid overall, waiting for sufficient numbers of outcomes such as hospitalisation, intensive care visits, or death, would increase the duration, size, and cost of the trial, and maybe significantly so. 2) Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Peer review isn’t necessary for the drug approval process, and takes a significant amount of time and effort that the people involved probably didn’t have. If it’s between writing a regulatory submission versus a manuscript, in this situation prioritising the activity that will likely directly save lives is reasonable. The manuscripts and ever-so-important peer review will follow soon.

rualca 6y ago
> Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Making results available to peers is the basis of science, which is a short word that means being sure things work as we think they do. Without peer review, no one has any idea of what the vaccine does. What if the vaccine is nothing but a big old placebo? How can we tell? It's far more than mere "bitching". Way more than that. The Royal Society's motto is 'Nullius in verba', which means "take nobody's word for it". Think about it. Of all places to hear that blend of anti-science, I wasn't expecting to read it here.
- newen 6y ago
  Peer review is the specific process of sending your well edited manuscript to a select few reviewers of a journal in order to get that manuscript published in that journal. It is different from having your results available to your peers, which I'm not sure they did that here, but point being peer review is this specific time consuming process (that can take months, sometimes years).
  - irthomasthomas 6y ago
    You are picking on one point out of many. Anyway, I think I would sleep better just knowing that they published everything, even if it doesnt get the formal peer review.
- mft_ 6y ago
  I can assure you it’s not being anti-science – it’s probably about a deeper understanding of how these things actually work. > Without peer review, no one has any idea of what the vaccine does. What if the vaccine is nothing but a big old placebo? How can we tell? This is what the regulatory authorities do. The FDA, the EMA, the MHRA, and many others. It is literally their job (amongst others) to make decisions on whether to approve drugs based on the data that they are provided with. The process of publishing data in a peer-reviewed journal is orthogonal to this. Sure, it’s an important part of the scientific process, but it is not part of the process to decide whether or not drugs work and should be approved. The only point that was being made is that in this sort of situation where delaying a few days means more people die, prioritising the regulatory approval process over submissions to a peer reviewed journal (if indeed that’s what happened) is entirely reasonable.

by mft_ 6y ago

rualca 6y ago

> Bitching about skipping the peer-review process in the face of a global pandemic is self-important nonsense. Making results available to peers is the basis of science, which is a short word that means being sure things work as we think they do. Without peer review, no one has any idea of what the vaccine does. What if the vaccine is nothing but a big old placebo? How can we tell? It's far more than mere "bitching". Way more than that. The Royal Society's motto is 'Nullius in verba', which means "take nobody's word for it". Think about it. Of all places to hear that blend of anti-science, I wasn't expecting to read it here.

newen 6y ago
Peer review is the specific process of sending your well edited manuscript to a select few reviewers of a journal in order to get that manuscript published in that journal. It is different from having your results available to your peers, which I'm not sure they did that here, but point being peer review is this specific time consuming process (that can take months, sometimes years).
- irthomasthomas 6y ago
  You are picking on one point out of many. Anyway, I think I would sleep better just knowing that they published everything, even if it doesnt get the formal peer review.
mft_ 6y ago
I can assure you it’s not being anti-science – it’s probably about a deeper understanding of how these things actually work. > Without peer review, no one has any idea of what the vaccine does. What if the vaccine is nothing but a big old placebo? How can we tell? This is what the regulatory authorities do. The FDA, the EMA, the MHRA, and many others. It is literally their job (amongst others) to make decisions on whether to approve drugs based on the data that they are provided with. The process of publishing data in a peer-reviewed journal is orthogonal to this. Sure, it’s an important part of the scientific process, but it is not part of the process to decide whether or not drugs work and should be approved. The only point that was being made is that in this sort of situation where delaying a few days means more people die, prioritising the regulatory approval process over submissions to a peer reviewed journal (if indeed that’s what happened) is entirely reasonable.