Lab confirmation of double masking can be performed in an afternoon. A clinical trial is going to take tens of thousands of self-reporting "I wore two" people for months or longer, plus difficulties with all sorts of confounding variables.
I'm very comfortable with a tentative recommendation based on the lab data for a non-dangerous intervention. If we get observational data a year from now confirming it, even better.
The timeframe of two years is simply not enough to be entirely sure, even with the large sample size. It is unlikely to have side effects, but the demand on proof is extensive and that isn't necessarily bad.
Looks promising. While it may seem obvious, I would spell out what double-blind means, the problem it solves, and how it is used elsewhere. That then sets you up to point out how doctors use these study types, adding credibility.
N of 1 is still worthy of discussion if the data is reliable. Have you considered trying to get someone to perform a double blind placebo controlled test on you?
You don't actually need a controlled double-blind study to notice a medical effect, IF the effect is sufficiently strong and consistent. Traditional "controlled double-blind studies" are nice to have, but are much too likely to accidentally reject good medicines and medical treatments of the sort that might be discovered and confirmed via this sort of personal experimentation. (Yes, false positives are bad, but false negatives are bad too!)
The era of personalized medicine is just beginning and these sort of devices seem unusually well-suited for that sort of approach.
Well that seems unreasonable? Double-blind just gives better comparability of results with lower N. Statistics wouldn't object to, say, giving all Italian patients the treatment and most Chinese patients not. You'd just end up with a more complex model and wider uncertainty, but if the medicine worked on a noticeable scale, you'd pick it up eventually.
This is a great point, and precisely why we're using two sensors and a simple voting algorithm in our first in man trial (3+ sensors and associated algorithms were deemed too risky by FDA for initial studies).
Double blinds are not the gold standard for science. They are not even the gold standard for medicine, although for drug studies in particular they have great utility. They actually have quite limited applicability outside of a particular set of circumstances.
The double blind study is a special construct created to deal with the confounding effect of placebos, which really isn’t a thing outside of medicine.
It could also simply be time. To me this is obviously a small study that should be followed up (quickly) with a double blind, randomized trial. Until then, I'd be hesitant to put a bunch of ppl on anticoagulants.
You make a very good point when you stress the importance of double blind studies of course. However, the problem of translating uncertain results into practice remains key in the medical research area. Who is going to fund your 100 studies with enough statistical power to reduce this uncertainty?
Two well controlled studies are required, so it really comes down to how the Phase 2 was structured and powered to see if it can count as the 2nd study.
I'm very comfortable with a tentative recommendation based on the lab data for a non-dangerous intervention. If we get observational data a year from now confirming it, even better.
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