[anthuswilliams]

No, in fact it is quite common to do "open label" clinical studies in which patients know what drug they are getting and no one is given the current standard of care. This is especially common in cancer, where the standard of care is so poor, and in rare diseases, where the patient population isn't large enough to admit such a comprehensive study.

It is harder to have the same statistical confidence of efficacy and safety in such studies, but clinical researchers try to address those issues by varying e.g. dosage quantities, time in between doses, etc.

Source: place I work is currently doing studies of this nature, and in general such studies seem to be well-understood and accepted by the FDA.

[s1artibartfast]

Randomization is independent from blinding. Open label studies can be either randomized or not, and controlled or not.

The FDA will usually push for blinding if possible (sometimes it is not). They will also usually push for a randomization zed control with standard of care. They way the FDA views it (and I agree), is that control patients are not harmed because they are still getting the same care they would outside of the trial.

It is usually unethical to have a treatment free arm. However, this has its own problem, where if you keep using equivalence comparisons, the end of the chain might not actually be any better