I am going to plan a randomized control trial. I have to compare one treatment in hemodilaysis hypertensive patients. I will compare this treatment with control group (without drug of interest). I will add placebo in control group. I want to know that either we will give placebo with other baseline drugs or in control group we will just only give placebo (no other drugs).
Secondly, Can anyone suggest me any software or website for covariate adaptive randomization?
There is a question of medical ethics here. Hypertensive patients receiving the placebo only may be getting care that is less than the standard of care for such patients, which would be unethical.
Further to Adam's point, the control group should receive current best practice. This is not just an ethical requirement, but also affects the interpretation of the trial. Your comparator regime provides the baseline against which the intervention is to be judged.
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