<<yes i will go on record to tell you that its not necessary to have randomized trials.
Why?
I presume that scans will be taken before and after treatment or some form of measurement and also some sort of scoring to see how patient is doing healthwise.
What is the purpose to give placebo to someone that has cancer - do you expect the placebo to do anything?
I am all for giving standard of care to one arm and 2 other arms with drug only and drug + standard of care? >>
Randomized trials don't give "placebo to someone that has cancer" unless placebo is the standard of care.
If you are suggesting that randomized trial are fine so long as they have three arms, including the experimental drug plus the standard of care, that makes sense only if there is reason to believe that standard of care plus the drug will be additive or at least not interfere with each other. The effect of the three arms is also to reduce the statistical power of the trial and make it somewhat harder to demonstrate that the experimental drug works in a statistically significant manner, unless you increase the size of the trial to compensatie -- which takes time and money.
If you are suggesting that randomized trials are not necessary because you can use scans to see "how the patient is doing healthwise", even if such a precise measure were possible, the question is, compared to what?
