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Do you really think you can avoid a trial by proving safety through statistical means? Aren't clinical trials done because we don't know in advance - as the fu
by DrScientist 6y ago
Do you really think you can avoid a trial by proving safety through statistical means?
Aren't clinical trials done because we don't know in advance - as the full complexity of biology is beyond our ability to predict?
ie we do the trials to find out the things we didn't know ( and thus couldn't model ).
Perhaps through rationalization of a trial result to avoid the call for additional trials - but I find it hard to believe trials can be avoided in general.
- ViralBShah 6y agoDo see: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence https://www.fda.gov/science-research/science-and-research-sp...
- DrScientist 6y agoThanks. Out of the categories of RWE - I'd say that the real time patient data collection looks the most promising - but then in some ways that's just clinical trial information collected in a different way.
- jogagobburu 6y agoI think the key "emergency use" is missed. The question is what are we going to do when you need something right away in a pandemic situation. The point here has nothing to do with "avoiding" trials - that I will never advocate. But there are enough situations that require us to think "outside the box". at that point, magic cannot happen. we need build things systemically as science progresses...
- DrScientist 6y agoEven in a pandemic situation, I'd not sure I'd ever use a model if I could do a phased rollout in terms of safety. And if it's so bad - that you have no option but to give it to everyone now - well you have no option... I suppose the practical problem right now is not so much about the risks of one individual vaccine, but rather choosing between the many many candidates. How would you go about that?