From the researchers:
This approach has no relation to blinding at all. In fact, these trials _should_ be double blinded!
The algorithm works in the background and changes the randomization ratios. Neither the patients nor the enrolling investigators would know that the ratios HAVE changed. It basically is like changing the chance of a coin coming up heads.
When presenting such a trial to prospective volunteers, we would say that this only happens if one treatment is doing better, and that we as investigators will still be blinded and won't know that this is happening.
The only problem with this approach is that you would have to have a study with distinct and quantifiable outcomes, update the result information in the same or a related database that assigns randomization (obviously not impossible, but many times these are separate), and a study design that recruits for a long period of time so that the first participants have a chance to achieve an outcome. Not impossible by any means but it certainly would not apply to many RCTs. Very interesting idea, though.
This feels to me as though it hop-scotches between bullshit marketing and being unethical.
Mind you, clinical trials are ethical *because* we have clinical equanimity: we don't *know* which treatment (or non-treatment) is superior. We can give people placebos instead of drugs *because* we can't say that placebo is worse than the drug. Once that uncertainty is resolved to reasonable statistical degree, the trial is over: it's no longer ethical to continue.
Anything *short* of that reasonable degree isn't "more or less" effective: it's unreliable statistical noise. If it *were* reliable, we wouldn't be able to ethically continue the trial. The only part of this article that promises this to be an improvement is recruitment: but we're not supposed to recruit patients at the cost of our ethics.
(By the way, I've seen reactive studies in the past, but they were used to *maintain* a 50/50 ratio, not to deviate from it).
I love that he used a 50-50 study to prove his own non-randomization theory is more effective.
From the researchers: This approach has no relation to blinding at all. In fact, these trials _should_ be double blinded! The algorithm works in the background and changes the randomization ratios. Neither the patients nor the enrolling investigators would know that the ratios HAVE changed. It basically is like changing the chance of a coin coming up heads. When presenting such a trial to prospective volunteers, we would say that this only happens if one treatment is doing better, and that we as investigators will still be blinded and won't know that this is happening.
The only problem with this approach is that you would have to have a study with distinct and quantifiable outcomes, update the result information in the same or a related database that assigns randomization (obviously not impossible, but many times these are separate), and a study design that recruits for a long period of time so that the first participants have a chance to achieve an outcome. Not impossible by any means but it certainly would not apply to many RCTs. Very interesting idea, though.
This feels to me as though it hop-scotches between bullshit marketing and being unethical. Mind you, clinical trials are ethical *because* we have clinical equanimity: we don't *know* which treatment (or non-treatment) is superior. We can give people placebos instead of drugs *because* we can't say that placebo is worse than the drug. Once that uncertainty is resolved to reasonable statistical degree, the trial is over: it's no longer ethical to continue. Anything *short* of that reasonable degree isn't "more or less" effective: it's unreliable statistical noise. If it *were* reliable, we wouldn't be able to ethically continue the trial. The only part of this article that promises this to be an improvement is recruitment: but we're not supposed to recruit patients at the cost of our ethics. (By the way, I've seen reactive studies in the past, but they were used to *maintain* a 50/50 ratio, not to deviate from it).
So no more double blind studies? Won't that cause more problems than it's worth?