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Question for people who understand the Phase 3 process - would the first step in an investigation of this type be to "unblind" the patient with the adverse reac
by tjmc 6y ago
Question for people who understand the Phase 3 process - would the first step in an investigation of this type be to "unblind" the patient with the adverse reaction to see if they got the vaccine or a placebo?
Seems to me if the reaction wasn't caused by the vaccine there's a 50/50 chance this person received a placebo. In which case, you could instantly discount the vaccine being the cause.
- abiogenesis 6y agoInterestingly placebo-induced adverse reaction is also a thing: https://pubmed.ncbi.nlm.nih.gov/10367099/ https://pubmed.ncbi.nlm.nih.gov/10367099/
- lbeltrame 6y agoThe principal investigator of the trial knows who got placebo and who did not, although neither the people working on the data nor the clinical staff know. It's likely that the participant will be "unmasked" to see why the adverse event occurred.
- deleted 6y ago[deleted]
- ageitgey 6y agoI'm in the trial. We all got little cards with our trial number to keep in our wallet. If we get seriously ill or end up in a hospital, there's a number for the doctor to call to unblind us if necessary. So there is definitely a procedure in place. Even if the person got the vaccine, the illness could be unrelated. They need time to investigate and this is the proper procedure to follow. This happened once before earlier in the trial, but it wasn't reported as widely and there want a media frenzy. There is nothing wrong with the media reporting this, but it would be great if the media was better at contextualizing information instead of maximizing clicks with scary headlines.