I don’t think it’s useful to speak in terms of blinding. The operational definition of blinding is not about whether someone knows that they take a drug but whether efforts were made to make it harder for them to know. In many cases, patients still know because there are immediate signs of taking verum.
The groups are picked at random from a population picked as randomly as possible (this is the randomized bit). Within limits, you obviously want to only pick Alzheimer suffering women for a drug meant to treat Alzheimer in women.
No, randomized generally only means that there’s randomization between whether someone in the clinical trial ends up in the verum or placebo group. Clinical trials for drugs are often made by looking for an ideal trial population where the company believes the drugs will be most effective. That often means that the participants in the trial take fewer other drugs to avoid side effect interactions.
Clinical trials for drugs are often made by looking for an ideal trial population where the company believes the drugs will be most effective. That often means that the participants in the trial take fewer other drugs to avoid side effect interactions.
It depends on how you read the evidence, if you are using the trial info in good faith (rather than as just approval tool), the laxer the selection criteria the better, since you can assume more “noise” is accounted for.
There’s an idea that RCTs produce some kind of objective evidence that’s independent of how you read it. Understanding that the trial environment is different in various ways from the actual clinical environment is important to understand that there’s a need for translation and that needs subjective calls.
I don’t think it’s useful to speak in terms of blinding. The operational definition of blinding is not about whether someone knows that they take a drug but whether efforts were made to make it harder for them to know. In many cases, patients still know because there are immediate signs of taking verum.
For that reason, it’s better to use the original terminology of masking than the misleading talk of blinding. (see more at https://www.lesswrong.com/s/5CNs9wmHWFQTNjFKo/p/grQQynyy6Mc4agJxu )
No, randomized generally only means that there’s randomization between whether someone in the clinical trial ends up in the verum or placebo group. Clinical trials for drugs are often made by looking for an ideal trial population where the company believes the drugs will be most effective. That often means that the participants in the trial take fewer other drugs to avoid side effect interactions.
As far as solutions to this overall problem go, switching from Evidence-Based Medicine to Prediction-Based Medicine would be helpful.
It depends on how you read the evidence, if you are using the trial info in good faith (rather than as just approval tool), the laxer the selection criteria the better, since you can assume more “noise” is accounted for.
--an
Agree with everything else that you said.
There’s an idea that RCTs produce some kind of objective evidence that’s independent of how you read it. Understanding that the trial environment is different in various ways from the actual clinical environment is important to understand that there’s a need for translation and that needs subjective calls.